Director/Senior Director, Biostatistics

Responsibilities:
- Lead and coordinate statistical activities to support clinical studies, including design, execution, analysis, interpretation, and reporting of clinical trials.
- Support statistical aspects of business-critical and/or regulatory commitments; provide input to program plans; represent Biostatistics for cross-functional working groups.
- Prepare or review clinical study protocols, case report forms, statistical analysis plans, and table shells.
- Create or validate SAS programs for data management, compliant analysis datasets, and statistical analyses.
- Prepare statistical sections of clinical trial reports and presentations.
- Apply regulatory guidance and statistical methodology to pharmaceutical clinical studies.
- Write statistical reports and memos with minimal guidance.
- Validate complex datasets and summary tables.
- Prepare and document facts; other duties as assigned.

Qualifications:
- Master’s degree in statistics/biostatistics or related field; PhD preferred.
- 12+ years clinical trials experience, including 5+ years in oncology clinical trials.
- Experience with solid tumor oncology and global NDA/BLA submissions (preferred).
- Experience leading phase 3 oncology trial design, execution, and reporting (preferred).

Skills:
- Strong knowledge of SAS and R; Splus and SQL are a plus.
- Ability to write and communicate clearly.
- Strong urgency, organization, problem-solving, and independent judgment/decision-making.
- Continuous improvement mindset; flexible and willing to learn.

Benefits/Instructions:
- Annual performance incentive bonus, new hire equity package, medical/dental/vision, 401(k) match, PTO, and paid holidays.