Principal Biostatistician Consultant (Oncology)
C
ClinChoiceOncology Clinical Trials
United StatesContractPrincipal
Salary not disclosed
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Job Details
- Experience
- 8+ years (MS) or 6+ years (PhD)
- Required Skills
- R
Requirements
- PhD or MS in Statistics, Biostatistics, or related field
- 8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics
- Strong experience in oncology clinical trials
- Hands-on experience with survival analysis, time-to-event endpoints, and complex oncology study designs
- Proficiency in SAS and/or R
- Strong knowledge of CDISC standards (SDTM, ADaM)
- Experience supporting regulatory submissions
- Excellent communication and leadership skills
Responsibilities
- Provide statistical leadership for oncology clinical trials across multiple phases (Phase I–III)
- Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs)
- Design and review statistical methodologies for efficacy and safety analyses
- Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards
- Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs
- Collaborate with clinical development, data management, programming, regulatory, and medical teams
- Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA)
- Provide strategic input on study design, endpoint selection, and sample size calculations
- Mentor junior statisticians and provide technical guidance
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