Principal Biostatistician Consultant; Oncology Remote

United States

Clin Choice 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 while establishing a high‑trust environment with the client’s counterparts.

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.

• 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.

• 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.

• Experience with adaptive designs and Bayesian methods.
• Prior experience interacting with regulatory agencies.
• Experience in immuno‑oncology or hematology oncology.

Clin Choice is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We promote diversity and inclusion in our workforce.