Biostatistics Specialist at FHI360 NGO

Job Summary:

Supports lead statistician in such tasks as: drafting statistical analysis plans (SAPs) for interim and final reports; designing Table, Figure and Listing (TFL) shells based on SAP; statistical review of data collection forms; designing analysis data set specifications; analysis programming; and production and review of statistical reports. Propose randomization strategy, draft Randomization Plans for senior review, and design and create randomization programs and associated material for Randomization Statisticians or serve as Randomization Statistician. May serve as Independent Statistician to Data and Safety Monitoring Boards (DSMBs) for noncomplex DSMB reviews (e.g., without formal stopping boundaries). May train staff on BIOS systems (e.g. randomization, archiving) as needed.  As necessary, serve as lead statistician for studies of a straightforward nature with guidance from more senior statisticians. As lead, write SAPs, design statistical reports, represent department on study team, and be responsible for statistical project management. Experience in this role will provide necessary training for taking on additional lead statistician functions in the future.  

Accountabilities:

• Using specification documents, write statistical analysis programs using SAS or other statistical software to generate or validate analysis data sets and tables, figures, listings (TFL) for statistical reports.
• As validator, investigates source of discrepancies in data and/or program code; reviews completed TFL for accuracy, including textual material (titles, headings, footnotes, etc.).
• Write and maintain accurate program documentation, and generate TFL shells from existing macro or other sources.
• Develop analysis data set and TFL specifications by modifying existing specs from similar studies or developing from data collection forms.
• Write analysis programs in SAS or other software.
• Design and generate TFL shells and analysis data set specifications, using protocol, statistical analysis plan, or other study materials.
• Carry out intermediate level statistical analysis, and assess validity of analysis assumptions.
• Help draft statistical sections of study reports.
• Review study reports and manuscripts for accuracy of reporting and inference.
• Work independently on unblinded interim analyses.
•  As lead statistician, manage the accurate and timely delivery of statistical services.

Applied Knowledge & Skills:

• Solid working knowledge of intermediate statistical methods for observational and randomized studies.
• Intermediate knowledge of statistical software packages, particularly SAS/BASE, macro, and data-step programming.
• Solid understanding of scientific and ethics principles in research study design and research analysis, including principles of randomization.
• Solid understanding of special requirements pertaining to unblinded interim analysis.
• Working knowledge of industry best practices and regulatory requirements pertaining to statistical analysis and analysis programming. ● Ability to show initiative, good judgment, and resourcefulness.

Problem Solving & Impact:

• Transforms broadly described concepts into detailed and accurate operational instructions.
• Uses logic and understanding of scientific reporting to make appropriate decisions regarding data handling
• Works on problems requiring analysis and interpretation of data
• Translates previously learned skills to new context with minimal direction.

Supervision Given/Received:

• Reports to a more senior statistician and/or supervisor on variances and status.
• Works under very general guidance from manager or more senior statisticians.
• With minimal supervision, manages a moderate to high volume work flow.
• Respond to most inquiries independently and follows up on requests efficiently.
• Uses judgment to execute duties and responsibilities.
• As lead statistician, may review the work of junior staff on specific tasks but does not have general supervisory responsibilities.

Education:

• Masters’ degree (or international equivalent) in statistics, biostatistics, bioinformatics or similar curriculum.

Experience:

• Typically requires 5-8 years’ relevant work experience in statistical analysis of research studies
• Demonstrated growth in the application of basic skills (e.g. planning and conducting analysis)
• Demonstrated skills in multiple statistical areas.
• Excellent interpersonal communication skills, verbal and written English.
•  Experience in statistical aspects of study design.  

Typical Physical Demands:

• Typical office environment.
• Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
• Ability to sit and stand for extended periods of time. ● Ability to lift/move up to 5 lbs.  

Technology to be Used:

• Personal Computer/Laptop, Microsoft applications (i.e., Office 365, SharePoint, Skype/Zoom/Teams), cell phone/mobile technology, and standard office equipment.

Travel Requirements:

• Less than 10%