Biostatistics Specialist

Key Responsibilities

• Statistical Programming: Write and validate statistical analysis programs using SAS or other software to generate analysis data sets and TFLs for reports.
• Data Validation: Investigate discrepancies in data and program code, and review TFLs for accuracy, including textual content like titles and footnotes.
• Documentation: Write and maintain accurate program documentation and generate TFL shells from existing macros or other sources.
• Analysis Design: Develop analysis data set and TFL specifications by modifying existing templates or creating new ones from data collection forms.
• Report Preparation: Draft statistical sections of study reports and review manuscripts for the accuracy of reporting and inference.
• Randomization: Propose randomization strategies, draft Randomization Plans for senior review, and design randomization programs.
• Independent Analysis: Work independently on unblinded interim analyses and potentially serve as an Independent Statistician to Data and Safety Monitoring Boards (DSMBs) for non-complex reviews.
• Leadership: Manage the accurate and timely delivery of statistical services for straightforward studies as a lead statistician.

Requirements and Qualifications

• Education: Master’s degree (or international equivalent) in statistics, biostatistics, bioinformatics, or a similar curriculum.
• Experience: Typically requires 5-8 years of relevant work experience in the statistical analysis of research studies.
• Technical Skills: Solid working knowledge of intermediate statistical methods for observational and randomized studies; proficiency in SAS (BASE, macro, and data-step programming).
• Regulatory Knowledge: Working knowledge of industry best practices and regulatory requirements pertaining to statistical analysis and analysis programming.
• Communication: Excellent interpersonal communication skills, with verbal and written fluency in English.
• Physical Demands: Ability to spend long hours at a computer screen, perform repetitive keyboard work, and lift or move up to 5 lbs.

Technology and Tools

• Personal Computer/Laptop.
• Microsoft Office 365 (Word, Excel, SharePoint, Skype/Zoom/Teams).
• Standard office equipment and mobile technology.

How to Apply

Interested and qualified candidates should apply online via the FHI 360 careers portal. Please visit the following link to begin the application process: Apply for Biostatistics Specialist. This link will redirect you to the official FHI 360 Workday recruitment portal.