Job Description
Role Summary Conduct and validate sample size determinations and statistical power analyses for standard clinical trial designs. Create statistical analysis plans (SAPs), shells for tables/listings/figures (TLFs), and statistical reports across studies of varying complexity. Serve as the lead statistician for randomization activities, including preparation of randomization documentation and generation of randomization schedules. Participate in client-facing interactions such as study initiation meetings, timeline and resourcing discussions, bid presentations, and blinded data review meetings. Review and quality-check case report forms (CRFs) and data management documentation, including edit check specifications, data review plans, and data transfer specifications. Perform QC reviews of statistical programming outputs such as specifications, analysis datasets, and TLFs to ensure alignment with statistical analysis requirements. Provide guidance and mentorship to statistical programmers regarding study design concepts and implementation of statistical methods. Support and mentor junior or mid-level biostatisticians in statistical tasks and project-related activities. Qualifications Master’s degree or higher in Biostatistics, Statistics, Mathematics, or a related scientific field preferred, with hands-on experience supporting FDA New Drug Application (NDA) submissions; a bachelor’s degree with equivalent relevant experience will also be considered. 5-10 years of hands-on experience in clinical trial biostatistics. Strong proficiency in SAS and R programming, including Base SAS, SAS Macros, SAS/GRAPH, SAS/STAT, and end-to-end clinical reporting workflows. Solid working knowledge of CDISC standards, including CDASH, SDTM, and ADaM. Demonstrated experience in developing and reviewing Statistical Analysis Plans (SAPs) and outputs, incorporating appropriate missing data handling methods such as multiple imputation.