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Principal Biostatistician - MA Licensed
Job in
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-03-05
Listing for:
Virtual Vocations Inc
Full Time
position Listed on 2026-03-05
Job specializations:
-
IT/Tech
Data Security, Data Scientist
Job Description & How to Apply Below
A company is looking for a Principal Biostatistician FSP, Clinical Safety (DMC/Unblinded).
Key Responsibilities Provide statistical leadership for early phase studies and conduct safety analyses for Phase 2/3 trials Serve as an unblinded DMC statistician across multiple studies, ensuring compliance with sponsor and regulatory requirements Participate in study design discussions and develop Statistical Analysis Plans (SAPs) and clinical study reports (CSRs) Qualifications & Experience Master's degree in Statistics, Biostatistics, or a related discipline;
PhD strongly preferred 5+ years of experience in clinical trials within the pharmaceutical or biotechnology industry; CRO experience preferred Proven experience in leading early phase clinical trials and conducting safety analyses for phase 2/3 trials Strong knowledge of ICH guidelines and regulatory expectations Proficient in SAS programming and solid understanding of CDISC standards for regulatory submissions
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