Biostatistics Specialist at FHI360 NGO

• 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.

• 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.

• 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.

• 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.

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

• 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.

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