Clinchoice Inc.
Principal Biostatistician Consultant- Remote in US (Oncology)
United States · Principal
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About the role
- We are seeking an experienced Principal Biostatistician to provide statistical leadership for oncology clinical development programs.
Responsibilities
- Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs).
- Design and review statistical methodologies for efficacy and safety analyses.
- Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs.
- Provide strategic input on study design, endpoint selection, and sample size calculations.
- This role will support Phase I-III clinical trials and contribute to regulatory submissions while collaborating closely with cross-functional teams.
Requirements
- 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.
- PhD or MS in Statistics, Biostatistics, or related field.
- Excellent communication and leadership skills.
Nice to have
- Experience with adaptive designs and Bayesian methods.
- Prior experience interacting with regulatory agencies.
- Experience in immuno-oncology or hematology oncology.
- 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.
- Who will you be working for?
- About ClinChoice
Benefits
- 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).
Company info
- 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.
Visa & Work Authorization
- 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
This listing is sourced directly from Clinchoice Inc.'s careers page and normalized into a canonical job model.