SOLICITATION NOTICE
R -- Lead Scientific Data Analyst
- Notice Date
- 10/15/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 923120
— Administration of Public Health Programs
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2009-N-10992
- Archive Date
- 11/14/2008
- Point of Contact
- Terren J. Grimble,, Phone: 7704882487, Rafael A. Aviles,, Phone: 770-488-2805
- E-Mail Address
-
TGrimble@cdc.gov, raviles@cdc.gov
- Small Business Set-Aside
- Total Small Business
- Description
- Description: The Department of Health and Human Services, Centers for Disease Control and Prevention, is seeking applications from qualified applicants for a Lead Scientific Data Analyst position located in Gaborone, Botswana. The resultant contract shall be a Personal Services Contract (PSC). See PL 109-149, Section 215(1), Reference 22U.S.C.2669(c). SOLICITATION NUMBER: 2009-N-10992 POSITION NUMBER: BW-PSC-01 ISSUANCE DATE: 10/15/2008 CLOSING DATE/TIME: 10/30/2008 at 3:00PM Eastern Standard Time POSITION TITLE: Lead Scientific Data Analyst BASIC SALARY: $ 51,095 to $ 88,015 per year -- Final compensation will be based on individual salary history, work experience, and educational background. PERIOD OF PERFORMANCE: One Base Year and Four Option Years PLACE OF PERFORMANCE: Gaborone, Botswana SECURITY CLEARANCE: NACI (Non-sensitive) AREA OF CONSIDERATION: United States Citizens and residents and third country nationals. Citizens and permanent residents of the host country are not eligible for this position. Duties and Responsibilities: • Provide management direction for all data collection, data management, and data analysis activities for HIV Prevention Research (HPR) activities including direct supervision of senior data manager, statistical analyst, and applications manager positions. Provide management direction for system development, training, and maintenance, including all software used for data collection by HPR. Provide management direction in the design and implementation of data quality management procedures and reporting. Identify and characterize methods to resolve and monitor resolution of problems with data validity, completeness, coding, timeliness, or data system efficiency. Evaluate, guide, or implement possible alternative approaches to data collection and data management. Contribute to the design and revision of CRFs. Evaluate trial performance data (event reporting). • Collaborate with CDC investigators in the design and implementation of HPR research, including clinical trials, surveys, observational studies, and operations research. Oversee development of DSMB report and collaborate with CDC trial statisticians in preparing DSMB reports. Consult with laboratory and other external data systems teams to facilitate integration of those data sources with the main HPR research databases. Contribute to close out of trial and final reporting. • Ensure that clean and complete datasets are provided for timely analysis by HPR investigators and CDC statisticians. Create analytical datasets for statisticians. Using Clindex, SQL, QDS, and other software as needed to develop, test, and validate data entry, management, and reporting programs and to document procedures in SOPs. • Ensure data collection and management procedures are conducted in compliance with the FDA Good Clinical Practice and Good Clinical Laboratory Practice standards. Manage protocol deviations and violations. Provide ongoing documentation of trial. Manage trial SOPs. Ensure data related SOPs are followed. Responsible for records management including archiving of all clinical trial records. • Evaluate clinical trial processes and troubleshoot process flow problems. Support compliance with clinic and laboratory procedure manuals and process maps. Monitor the clinical trial using Clindex and SAS to identify areas of concerns (e.g., patient results that require attention, seemingly discordant results, weekly reports on trial statistics, etc.). Ensures queries and questions are monitored and outstanding queries are followed up for resolution. Provide support to clinic flow particularly related to data and documentation. From statistical reporting on staff performance, identify areas for improved efficiency. • Ensures study staff is trained in standardized data collection, entry, and management procedures to achieve integrated, valid, accurate, and timely data collection and management for HPR studies including but not limited to clinical trials, surveys, observational studies, and operations research. • Perform other duties as assigned by the Associate Director for HIV Prevention Research. Major Duties of this position include: The position will supervise 3 PSA positions: 1 Senior Data Manager who supervises 4-8 other PSA positions; 1 Statistical Analyst; and 1Applications Manager. When data entry tasks are outsourced, this PSC will assist with managing contractors completing these tasks. This PSC has personal responsibility for a PC desktop (approximate value $2,000). The PSC also oversees the positions responsible for Clindex licenses ($35,000 initial/$20,000 per year ongoing), Labware - initial cost $187.00, $27,000 annual license fee. Total dollar value: $43,000 initial/$21,000 additional yearly The PSC will review supply requests from the HPR Data Section. Ensures study forms are ordered and available at clinics. Total supply purchases per year for the HPR Data Section is an estimated $40,000. The PSC will be responsible for formulating a budget for the HPR Data Section including planning for purchasing of new software and equipment. Estimated annual budget $100,000. The PSC has overall responsibility for large databases (over 300,000 records) that have confidential clinical information on patients. Oversees access to these databases that have tens of thousands of controllable items for HPR employees through password protected codes. The PSC may serve as the COTR for small contracts (less than $25,000). The PSC is directly supervised by the Associate Director for HIV Prevention Research. The supervisor typically provides broad direction. The supervisor sets the overall objectives and, in consultation with the employee, determines timeframes and possible shifts in staff or other resources required. The employee independently plans and carries out projects and analyses of the organization's requirements; interprets policies, procedures, and regulations in conformance with established mission objectives; integrates and coordinates the work of others as necessary; and, resolves most conflicts as they arise. Incumbent informs the supervisor about progress, potentially controversial matters, or matters with far reaching implications. Completed work is reviewed from an overall standpoint in terms of feasibility, compatibility with other work, or effectiveness in meeting requirements or achieving expected results. The PSC must utilize the most sophisticated technical information, state-of-the-art technology, and innovative infrastructure strategies to plan and coordinate several stages of system development life cycle management such as hardware/software design, database administration and customer support. The PSC defines requirements, coordinates design, development and implementation, and resolves technical and management issues as required. The PSC must triage, diagnose, and resolve complex problems related to clinical trial management, database technology, data collection, and database administration, which requires logical thinking and the ability to postulate multiple solutions (for example, the PSC will troubleshoot clinical trial process flow problems and make recommendations for improved efficiencies). The development of unique applications and procedures requires creative application of existing technology and the interfacing of various hardware and software options. The PSC is required to evaluate and analyze current technical trends, and develop and implement new program applications. Approaches must be both technically sound and practical. The PSC exercises sound judgment, originality and resourcefulness to assure the technology environment supports the customer's needs and requirements. The work regularly requires the development of new operational policies, practices, methods, and techniques to accommodate the needs of HIV Prevention Research activities. The PSC assists in development and implementation of new guidelines. The PSC oversees highly specialized instructions and training to data managers in the use of Clindex, Microsoft Excel and Access. Clindex is a unique software application that is not commonly used in Botswana. The use of Excel and Access are also adapted specifically to the research trial and all work done will need to be clearly defined and communicated by incumbent to other trial staff. Incumbent advises study staff (including counselors, nurses, interviewers, medical officers, and protocol operations managers) on critical aspects of completion of case report forms, form completion shortcomings, and visit synchronization for returning study participants, and ensures compliance. The PSC troubleshoots clinical trial process flow problems and makes recommendations for improving efficiencies. Incumbent provides advice to individuals inside and outside of the organization, such as officials of the Ministry of Health, contractors, representatives of software corporations, public health officials from different countries, and scientists from universities about ways to facilitate correct data entry, to present data in a logical manner, and on use of computer or other information technology devices. The PSC will alert the Associate Director for HPR of any concerns re: data management and analysis and will recommend solutions to any problems encountered. The work of the PSC directly impacts the success of the clinical trials being conducted by the CDC HIV Prevention Research section in Botswana. This PSC has overall responsibility for data integrity and ensures that the data is of the highest quality. This data is regularly reviewed by a Data Safety Monitoring Board which makes all decisions regarding the trial based on the data. Poor quality data could result in the clinical trials being stopped by the DSMB. The entire endeavor, which has cost years of effort and millions of dollars, could be jeopardized. Recommendations for implementing HIV prevention activities as a result of the clinical trial are based on the data. The PSC will interact with Botswana Ministry of Health, vendors and colleagues from universities, NGOs, international organizations, etc. The PSC will be expected to represent HPR at international conferences and meetings where s/he will be presenting findings from the studies and will have an impact on the way in which the studies are perceived internationally. Knowledge: Essential: Knowledge of HPR program goals and objectives and the relationship with other programs and key functions internal or external to CDC. Knowledge of PC-related data management and/or maintenance principles and techniques and services to evaluate alternative approaches in recommending solutions to problems related to PC database management. Knowledge of a wide range of PC computer techniques, requirements, methods, sources, and procedures to perform a variety of database-related assignments in the application or specialty area. Knowledge of PC database management software and database management systems development (including database software systems documentation, design development, configuration management, cost analysis, data administration, systems integration, and/or testing) to analyze the software requirements of a computer system and determining the best development and/or programming approach. Knowledge of PC-based statistical software (SAS) and the ability to perform statistical analyses on databases to identify errors and inconsistencies and to produce descriptive tables for subsequent reports. Master's Degree Training in the following software packages is required for this position: Microsoft Excel and Access, EpiInfo6, EpiInfo2000, SAS.. Minimum seven years experience with microcomputers in Windows and DOS environment is essential. Experience is also required in the installation, management and optimal usage of software. At least two years of supervisory experience is required. English Level 4: Fluent Advanced computer skills in word processing, data management and spreadsheets. Candidate must possess effective verbal and written communication skills. Time required for a qualified outside job holder to perform the full range of duties and responsibilities of the job after first entry into the position 6 months. Desired: General knowledge and familiarity with the health problems, customs, and culture of Africa, particularly Botswana. Also useful if candidate has completed basic cultural competency training in the past. Doctoral Degree Project Management (PMI) certification. Clindex is a unique software application that is not commonly used in Botswana. Prior experience using Clindex software is desired. Experience working in a developing country. Experience working with clinical trials. Intellectual Skills: Performance of the assigned studies, design projects, database system software evaluations may require deviating from traditional methods or researching trends and patterns to develop improved methods or to formulate criteria. Employee uses initiative and resourcefulness in researching and implementing state-of-the-art techniques and technologies in order to develop new and improved methods to cope with particular projects. Guidelines include FDA regulations, Good Clinical Practice guidelines, Standard Operating Procedures. The work includes varied duties requiring many different and unrelated processes and methods involving oversight of all data for a complex HIV clinical trial in Botswana. Decisions regarding what needs to be done are impacted by the social, cultural, economic, governmental, political, and other features of the environmental setting and include areas of uncertainty in approach, methodology, or interpretation and evaluation processes. The PSC must utilize the most sophisticated technical information, state-of-the-art technology, and innovative infrastructure strategies to plan and coordinate projects that involve several stages of system development life cycle management, such as hardware/software design, database administration and customer support. The PSC defines project requirements, coordinates design, development and implementation, and resolves technical and management issues as required. The PSC must triage, diagnose, and resolve complex problems related to database technology, data collection, and database administration, which requires logical thinking and the ability to postulate multiple solutions. The development of unique applications and procedures requires creative application of existing technology and the interfacing of various hardware and software options. The PSC is required to evaluate and analyze current technical trends, and develop and implement new program applications. Approaches must be both technically sound and practical. The PSC exercises sound judgment, originality and resourcefulness to assure the technology environment supports the customer's needs and requirements. The work requires significant planning ahead. The PSC must forecast budgetary needs for the entire fiscal year 3 months before the beginning of the fiscal year. Personal leave should be scheduled 3- 6 months in advance. The PSC plans own work and reviews proposed work of staff one month in advance but requires flexibility to adjust work plans to accommodate the data needs of the clinical trial. This work requires a high degree of innovation. The PSC must design new databases; must be able to convert old datasets into new software packages without compromising data integrity; must overcome problems in reconciling data differences in large databases; and must be able to develop software solutions and routines to carry out analyses of data in SAS and Clindex. Communications: --- Level of internal key contact and type of information communicated: The individual will communicate with CDC Atlanta software support personnel to resolve specific data related problems. The individual will communicate with CDC Atlanta statisticians and data management staff re: clinical trial data and DSMB reporting. --- Level of external key contact and type of information communicated The PSC will interact with all study staff (nurses, medical officers, laboratory technicians, counselors, data managers and other staff) regarding data management procedures and issues arising from HIV research. The PSC will present results of research to scientists and informatics specialists at local, national and international conferences. The PSC will provide technical assistance and consultation to Botswana Ministry of Health. The PSC will communicate verbally with HIV Prevention Research staff, BOTUSA staff, Embassy staff, vendors, partners, and research colleagues. The nature of the work will require the PSC to exercise initiative, persistence, tact, and resourcefulness in establishing and continuing work relationships and gaining the confidence, support and compliance of those contacted. The PSC will present work at meetings both to co-workers and colleagues at international meetings. The PSC is required to communicate effectively through email. The PSC will develop detailed instructions in standard operating procedures. The PSC will oversee the development of DSMB reports and collaborate with CDC trial statisticians in preparing DSMB reports. The individual will prepare regular written reports and will contribute to scientific manuscripts submitted for publication. Working Environment: The environment involves everyday risks or discomforts that require normal safety precautions. The work area is adequately lighted. The work is generally performed in an office on-site or at the site of the public health program. There may be some walking, standing or bending, and carrying of small and light objects. The work requires regular travel to HPR clinics in Gaborone and Francistown. Benefits/Allowances: Overseas allowances and differentials similar to those available to U.S. Government employees assigned abroad may be payable under this PSC, subject to eligibility. Actual benefits may vary from one candidate to the next and/or from one country of assignment to the next. A summary of the overseas allowances and differentials available to U.S. Government employees assigned abroad may be found at the following Internet URL: http://aoprals.state.gov/ Specific benefit, allowance, and differential information will be provided in the "Offer of PSC Employment" letter sent to the successful applicant. Additionally, country specific information useful for U.S. Government employees assigned abroad may be obtained from Department of State available at the following Internet URL: http://www.state.gov/m/fsi/tc/c10391.htm and Travel Warnings concerning certain countries, in many of which CDC conducts its international program activities, may be obtained at the following Internet URL: http://travel.state.gov/travel/cis_pa_tw/tw/tw_1764.html. Federal Taxes: Personal Service Contractors who are either United States citizens or Permanent Resident Aliens (i.e., "green card" holders) of the United States are not exempt from payment of Federal Income and, in some cases State, income taxes on salaries earned abroad while working for the U.S. Government. CONTRACTOR-MISSION RELATIONSHIPS (a) The contractor acknowledges that this contract is an important part of the U.S. Foreign Assistance Program and agrees that his/her duties will be carried out in such a manner as to be fully commensurate with the responsibilities that this entails. (b) While in the Cooperating Country, the contractor is expected to show respect for the conventions, customs, and institutions of the Cooperating Country and not interfere in its political affairs. (c) If the contractor's conduct is not in accordance with paragraph (b) of this provision, the contract may be unilaterally terminated by the Contracting Officer. The Contractor recognizes the right of the U.S. Ambassador to direct his/her immediate removal from any country when, in the discretion of the Ambassador, the interests of the United States so require. (d) The Country Director is the chief representative of CDC in the Cooperating Country. In this capacity, he/she is responsible for the total CDC Program in the Cooperating Country including certain administrative responsibilities set forth in this contract and for advising CDC regarding the performance of the work under the contract and its effect on the U.S. Foreign Assistance Program. The contractor will be responsible for performing his/her duties in accordance with the statement of duties called for by the contract. However, he/she shall be under the general policy guidance of the Country Director, and shall keep the Country Director or his/her designated representative currently informed of the progress of the work under this contract. SOCIAL SECURITY, FEDERAL INCOME TAX AND FOREIGN EARNED INCOME (a) Since the contractor is an employee, F.I.C.A. contributions and U.S. Federal Income Tax withholding shall be deducted in accordance with regulations and rulings of the Social Security Administration and the U.S. Internal Revenue Service, respectively. (b) As an employee, the contractor is not eligible for the 'foreign earned income' exclusion under the IRS Regulations (see 26 CFR 1.911- 3(c)(3)). INSURANCE (a) Worker's Compensation Benefits. The contractor shall be provided worker's compensation benefits in accordance with the Federal Employees' Compensation Act. (b) Health and Life Insurance. (1) The contractor shall be provided a maximum contribution of up to 50% against the actual costs of the contractor's annual health insurance costs, provided that such costs may not exceed the maximum U.S. Government contribution for direct-hire personnel as announced annually by the Office of Personnel Management. (2) The contractor shall be provided a contribution of up to 50% against the actual costs of annual life insurance not to exceed $500.00 per year. (3) Retired U.S. Government employees shall not be paid additional contributions for health or life insurance under their contracts. The Government will normally have already paid its contribution for the retiree unless the employee can prove to the satisfaction of the Contracting Officer that his/her health and life insurance does not provide or specifically excludes coverage overseas. In such case, the contractor would be eligible for contributions under paragraphs (b)(1) or (2) as appropriate. (4) Proof of health and life insurance coverage shall be submitted to the Contracting Officer before any contribution is paid. On assignments of less than one year, costs for health and life insurance shall be prorated and paid accordingly. (5) A contractor who is a spouse of a current or retired Civil Service, Foreign Service, or Military Service member and who is covered by their spouse's Government health or life insurance policy is ineligible for the contribution under paragraphs (b)(1) or (b)(2) of this provision. MEDEVAC INSURANCE (NON U.S. CITIZENS ONLY) Non U.S. citizens will not qualify for health unit access during the period of performance of the resultant contract and, if a contract is offered, will be responsible for obtaining required medical evacuation (medevac) insurance. CDC shall reimburse 100% of the cost of medevac insurance maintained by the contractor. CDC does not require that contractor obtains coverage from any one specific company. The contractor is responsible for and has the discretion to choose a provider. For information purposes only: The Department of State maintains a list of U.S. based providers on the following website: http://travel.state.gov/travel/tips/health/health_1185.html. CDC provides no endorsement, expressly or implied, of any emergency medical service provider. Contractors have full discretion to consider providers not provided in this list, but are expected to verify that the coverage they do obtain will adequately cover an evacuation due to a medical situation that arises in the location of contract performance. CDC shall approve a fair and reasonable amount for obtaining the required coverage as a direct cost to the contract. In order for CDC to reimburse the cost of medevac insurance, CDC shall require the contractor to furnish evidence of obtaining medevac insurance for the employee and all accompanying family members on U.S. Government travel orders and its cost, after issuance of an offer letter. INHERENTLY GOVERNMENTAL FUNCTIONS An individual serving under a CDC PSC may not perform "inherently governmental functions," which include: • Committing the U.S. Government (USG) to a specific course of action or performing Services, which involve discretionary exercise of Government authority; • Exercising signatory authority on behalf of the USG; • Directing policy formulation or making policy decisions; • Approving program plans; • Officially representing the CDC (representation); • Controlling USG-owned property; • Acting as a cashier or sub-cashier; or, • Supervising Government FTE staff. An individual serving under a PSC may: • Provide advice or make recommendations to Government FTE staff; • Perform services (other then the prohibited services listed above) in support of program activities; • Direct projects or teams (as long as supervision of Government FTE staff is not involved); and, • Supervise other PSCs, Personal Services Agreement Employees (PSA), grantees or fellows. See FAR 7.5 for additional information regarding inherently Governmental Functions. How to Apply: A complete application shall consist of a completed Optional Form 612 (Optional Application for Federal Employment) or resume or curriculum vitae that provides the same information required in a OF 612, as well as references, current (or highest recent) salary documentation, and Benefit Eligibility Form. FAILURE TO SUBMIT ALL REQUIRED DOCUMENTATION LISTED ABOVE WILL RESULT IN YOUR APPLICATION NOT RECEIVING CONSIDERATION FOR SELECTION. Optional Form 612, Optional Application for Federal Employment: The Optional Form (OF) 612, Optional Application for Federal Employment, can be located at: http://www.opm.gov/Forms/html/of.asp. References: Each applicant shall submit three Professional references other than family members. Two references shall be from a current and previous supervisor. The following information is required: Name, Address, telephone Number, Title, and Email Address. Current (or Highest Recent) Salary Documentation: Each applicant shall submit supporting documentation that reflects their current or highest recent salary. Examples of such supporting documentation are the most recent earning statement, an official letter from current employer signed by the applicant's current supervisor or Human Resources Representative, or the applicant's most recent U.S. Federal tax return. Each applicant shall also include a letter indicating the minimum salary in U.S. dollars the applicant would accept for the position. Benefit Eligibility Form: Each applicant shall complete and submit with the application, the Benefit Eligibility Form located at the end of this solicitation. Submission of Application: A complete application package (OF 612 or equivalent, references, salary documentation, and Benefits Eligibility Form) must be received at the following location no later than the closing date and time identified above: Centers for Disease Control and Prevention Procurement and Grants Office Mailstop K75, Branch VII Attn: Terren J. Grimble, Contract Specialist Solicitation Number: 2009-N-10992 2920 Brandywine Road Atlanta, GA 30341-5539 Complete application packages may be emailed to the attention of Terren Grimble at ibi9@cdc.gov. Facsimile copies will not be accepted. Applications received after the closing date and time will not be accepted. Refer to Federal Acquisition Regulation 15.208 regarding submission of late proposals: (http://www.acqnet.gov/far/current/html/Subpart%2015_2.html#wp1125227). All applications must be legible and submitted in the English language. The solicitation number identified above must be included on all documents submitted with the application package, as well as any other correspondence regarding this solicitation. Selection Factors: The applicant that represents the best value to the Government will be considered for award of FETP Resident Advisor PSC. To determine best value, the following factors will be considered: 1. The extent an applicant meets the minimum and desired qualifications based on information obtained through the application package and interviews. Note that interviews may or may not be conducted; therefore, the application package should clearly identify how well the applicant meets the minimum and desired qualifications of this position. Interviews, if conducted, may be either in-person or via telephone. 2. Information collected from reference checks. References will only be verified for those applicants determined to have a reasonable chance of being selected for award. 3. Results of a cost assessment. The cost assessment will determine the total cost (salary plus benefits and allowances) of the applicant for the complete term of the contract (base period plus any option years). Basis for Award: In determining best value, paramount consideration shall be given to technical merit (applicant qualifications and reference checks) rather than to cost. In cases where applicants are determined to be essentially equal, then cost may become the determining factor. BENEFIT ELIGIBILITY FOR PSC CANDIDATE REQUIREMENT PROVIDE ADDITIONAL INFORMATION OR DOCUMENTATION: A. City and State (or Country, if not in U.S.), of Current Residence B. If Already Present in Country of Service, Reason for Current Presence There. N/A/ or reason for current presence in country, e.g., brought there by previous employer [provide name of employer, your status and job title, and whether housing and repatriation was included in employment package]; dependent of someone brought there by employer [provide name of employer and whether housing and repatriation is included in employment package], etc. C. Attach Copy of Front Page of Most Recent Passport, Showing Citizenship, Name, and Date and Place of Birth. See attached. D. Family Members Accompanying You to Location of Contract Performance: Spouse: Children Under Age 18 at Time of Arrival - How Many?: Please list name and date of birth of each E. Annual Education Travel for Children Up to Age 23 at Time of Your Arrival at Location of Contract Performance Who Are Attending a Recognized Post-Secondary Educational Institution on a Full-Time Basis Children Before 23rd Birthday at Time of Arrival Attending a Recognized Post-Secondary Educational Institution on a Full-Time Basis - How Many?: Please list name and date of birth and city and state (or country, if not in U.S.) of location of educational institution for each:
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=9f85270c899390e2fdc7670bb4c08f45&tab=core&_cview=1)
- Place of Performance
- Address: Gaborone, Botswana, Botswana
- Record
- SN01692042-W 20081017/081015215000-9f85270c899390e2fdc7670bb4c08f45 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |