Associate Director, Biostatistics, Oncology
Ascendis Pharma
- Palo Alto, CA
- Permanent
- Full-time
- Research, identify and implement statistical strategies for clinical programs, regulatory submissions, and regulatory interactions. Participate in regulatory interactions and provide biostatistics input.
- Serve as statistician on protocol design, endpoint selection and sample size calculation, case report form (CRF) design, statistical analysis plan (SAP), through clinical study report (CSR). Author documents or sections of documents as needed to ensure scientific rigor and internal consistency.
- Collaborate with the project team on trial execution.
- Support the need of ongoing data review by the cross-functional team and effectively communicate results and message to the project team, management team, and/or other stakeholders.
- Generate data summary and visualization to support internal decision-making.
- Ensure timely delivery of planned or ad hoc data analysis with high quality.
- Support statistical activities on IB, DSUR, publications, conference presentations, etc.
- Provide statistical and analytical support for Research, Translational Research, and CMC as needed. Contribute to the integration and analysis of totality of data. Derive insights across different data (such as biomarkers) by using appropriate statistical tools.
- Research and apply statistical modeling and simulation approaches as needed.
- Keep abreast of the evolving innovative statistical approaches, design considerations, and development in the relevant therapeutic areas.
- Effectively communicate complex statistical topics in a professional manner to statistical and nonstatistical audiences.
- Oversee the deliverables and analyses outsourced to CROs, as needed.
- Ph.D. or equivalent degree in statistics/biostatistics or related discipline with 5+ years, or Master's degree with 8+ years in the biotech, pharmaceutical or CRO setting.
- Proficiency in experimental design, statistical analysis methodologies, and related regulatory guidelines applicable to Clinical Research.
- Sound knowledge of theoretical and applied statistics.
- Strong analytical and problem-solving skills in identifying needs/risks and formulating solutions independently and proactively.
- Experience in oncology/hematology drug development is preferred.
- Proficient programming skills in SAS and R.
- Experience in managing and collaborating with CROs.
- Must have excellent people skills and ability to work successfully in a team environment.
- Excellent verbal and written communication and presentation skills.
- May require occasional evening and/or weekend commitment.
- Occasional domestic and international travel may be required.
- Salary range: $190-215K/year
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance