Principal Biostatistician Consultant- Remote in US (Oncology)
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 anPrincipal Biostatistician Consultant to join one of our clients. 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.
Key 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.
Qualifications
- 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.
Preferred Qualifications
- Experience with adaptive designs and Bayesian methods.
- Prior experience interacting with regulatory agencies.
- Experience in immuno-oncology or hematology oncology.
The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. #LI-TT1 #LI-Remote #Principal#Contract Apply To This Job