Principal Biostatistician Consultant- Remote in US (Oncology)

ClinChoice

7d•Remote

About The Position

ClinChoice is searching for a Principal Biostatistician Consultant to join one of our clients. This role will provide statistical leadership for oncology clinical development programs, supporting Phase I–III clinical trials and contributing to regulatory submissions while collaborating closely with cross-functional teams. The ideal candidate will be confident, able to work independently, and establish a high-trust environment with the client's counterparts.

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.