Principal Biostatistician Consultant
C
ClinChoiceClinical Research CRO
Remote in USContractPrincipal
Salary not disclosed
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Job Details
- Experience
- 8+ years (MS) or 6+ years (PhD) of industry experience
- 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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