Director of Biostatistics - Remote, Biotech

About the Company: This company is a publicly traded biotech focused on developing targeted cancer therapeutics. The organization applies a precision medicine approach, leveraging translational biomarkers and synthetic lethality to deliver therapies tailored to specific patient populations. It has established strategic collaborations with leading pharmaceutical companies and wholly owns its most advanced clinical programs.

Position Summary: The Director of Biostatistics will provide strategic and operational leadership in the planning and execution of clinical trials and regulatory submissions. Working closely with cross-functional teams—Clinical Development, Regulatory Affairs, Drug Safety, and others—this leader will ensure high-quality, timely statistical deliverables and uphold rigorous statistical standards across programs.

Key Responsibilities: Lead and manage cross-functional biostatistics support for clinical programs, ensuring alignment with development strategy. Provide strategic input on study design, clinical development plans, and regulatory strategy. Oversee authoring, review, and approval of key documents such as protocols, SAPs, CRFs, CSRs, and regulatory filings. Manage internal and external biostatistics teams, including contractors, CROs, and statistical programmers. Serve as a statistical expert to internal teams and external stakeholders including regulatory authorities and KOLs. Translate scientific and clinical questions into statistical methodologies and ensure their effective communication across teams. Remain current with statistical methodologies, clinical trial design best practices, and regulatory expectations.

Qualifications: PhD or MS in Biostatistics, Statistics, or a related field. 12+ years of industry experience in biostatistics for drug development, with at least 8 years in oncology. Demonstrated expertise in clinical trial design, especially in time-to-event analyses and adaptive trial methods. Hands-on experience supporting all phases of oncology clinical trials, including NDA/BLA submissions. Proven leadership in cross-functional drug development environments. Strong communication skills and ability to mentor, manage, and collaborate with internal and external teams. Seniority level Seniority level Director Employment type Employment type Contract Job function Job function Science Industries Biotechnology Research, Pharmaceutical Manufacturing, and Research Services Referrals increase your chances of interviewing at Bio Talent by 2x Inferred from the description for this job 401(k) Medical insurance Vision insurance Get notified about new Director Biostatistics jobs in United States. Sr. Director Biostatistics and Data Analytics United States $248,615.00-$341,846.00 4 days ago Palo Alto, CA $225,000.00-$240,000.00 1 month ago Senior Director Biostatistics Oncology (People Manager) United States $250,000.00-$300,000.00 1 week ago Director, Data and Science (Analytic Solutions) United States $200,000.00-$240,000.00 1 week ago Florida, United States $205,000.00-$255,000.00 2 weeks ago United States $180,000.00-$250,000.00 2 weeks ago Texas, United States $205,000.00-$255,000.00 2 weeks ago Irvine, CA $205,000.00-$255,000.00 2 weeks ago United States $253,000.00-$314,000.00 1 week ago United States $216,000.00-$248,000.00 1 week ago Associate Director, Medical Affairs Biostatistics United States $172,000.00-$237,000.00 1 week ago United States $230,000.00-$270,000.00 6 days ago United States $195,000.00-$225,000.00 5 days ago Executive Director, Biostatistics and Data Management Minneapolis, MN $205,000.00-$255,000.00 2 weeks ago United States $230,000.00-$265,000.00 3 weeks ago United States $190,000.00-$215,000.00 3 weeks ago United States $195,000.00-$215,000.00 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.