Sr Manager- AD Biostatistics Oncology
Associate Director, Biostatistics - Oncology (Remote)
Salary: 170,000 to 240,000 base + bonus + LTI + additional benefits
Location: United States (Remote)
Therapeutic Area: Oncology
Level: Sr Manager/Associate Director
Position Overview
We are seeking an accomplished Associate Director of Biostatistics to provide statistical leadership across early‑ and late‑stage oncology clinical development programs. This role will serve as a lead statistician on one or more oncology assets and will work closely with Clinical Development, Regulatory, Data Management, and other cross‑functional partners to support the successful execution of clinical trials from study design through regulatory submission.
This position offers the opportunity to make a significant impact within a growing oncology portfolio while working in a fully remote environment.
Key Responsibilities
- Serve as the lead statistician for oncology clinical trials spanning Phase I-III (early and/or late stage)
- Provide strategic statistical input into protocol design, including endpoints, sample size, randomization, and analysis plans
- Author and review Statistical Analysis Plans (SAPs), protocols, and related clinical documents
- Oversee and provide guidance to CRO statisticians and internal programming teams
- Contribute to regulatory interactions, including FDA/EMA meetings and responses
- Support clinical study execution, data review meetings, interim analyses, and final analyses
- Participate in the interpretation of clinical results and support publications and internal decision‑making
- Collaborate cross‑functionally with Clinical, Regulatory, Medical Writing, Data Management, and Biometrics leadership
- Mentor junior statisticians and contribute to the development of best practices within the Biostatistics function
Required Qualifications
- PhD in Statistics, Biostatistics, or a closely related discipline
- Minimum of 4+ years of industry experience within pharmaceutical or biotechnology companies
- Demonstrated experience as a lead statistician in oncology clinical trials
- Hands‑on experience across early and/or late‑phase clinical development
- Strong knowledge of clinical trial methodology, regulatory requirements, and statistical principles
- Experience working with CROs and cross‑functional clinical teams
- Excellent communication and stakeholder‑management skills
- Ability to work independently in a remote environment while contributing to a collaborative team culture
Preferred Qualifications
- Experience supporting regulatory submissions (e.g., NDA/BLA)
- Background in specific oncology indications (solid tumors and/or hematologic malignancies)
- Experience in a growing or mid‑sized pharmaceutical environment
Why Join Us
- Fully remote‑friendly culture with flexibility and autonomy
- Opportunity to influence strategic oncology programs
- Collaborative, science‑driven environment
- Competitive compensation, benefits, and long‑term growth potential
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