Principal Biostatistician Consultant_Oncology_ Remote in US
About The Position
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for an Principal Biostatistician Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Job Summary We are seeking an experienced Principal Biostatistician to provide statistical leadership for oncology clinical development programs. This role will support Phase I–III clinical trials and contribute to regulatory submissions while collaborating closely with cross-functional teams.
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.
Nice To Haves
- Experience with adaptive designs and Bayesian methods.
- Prior experience interacting with regulatory agencies.
- Experience in immuno-oncology or hematology oncology.
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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
