The Sr. Director of Biostatistics will provide statistical leadership, oversight, and expertise in support of the clinical development activities.This position will provide statistical guidance to innovative study designs that are suitable for Ascendis’ oncology clinical programs. This individual will collaborate closely with the cross-functional teams on protocol development, study execution, be responsible for data analysis and interpretation of results, and work closely with Data Management and Statistical Programming resources to achieve all Biometric deliverables and activities at CROs. Additional analysis support of non-clinical / biomarker /CMC data and derive insight to contribute to Ascendis’ scientific research may be requested. The role reports to EVP, Clinical Development Oncology.
Key Responsibilities
- Research, identify and implement statistical strategies for clinical programs, regulatory submissions, and regulatory interactions. Participate in regulatory interactions and provide biostatistics input.
- Serve as lead statisticianas needed 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.
- Lead 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 to advance the clinical development of Ascendis’ clinical development programs.
- Keep abreast of the evolvement in innovative statistical approaches and design considerations. Keep abreast of the development in the therapeutic areas in which Ascendis is engaged.
- Effectively communicate complex statistical topics in a professional manner to statistical and nonstatistical audiences.
- Manage CROs as needed. Oversee the deliverables and analyses outsourced to CROs.
- Partner and coordinate with Statistical Programming and Data Management to build Biometrics processes and infrastructure.
- May manage inhouse or contract statisticians and programming staff as needed.
Requirements
Knowledge, Skills and Experience
· Ph.D. or equivalent degree in statistics/biostatistics or related discipline with 10+ years, or Master’s degree with 12+ 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.
· Experienced with tactical analytical and problem-solving skills with track record of identifying needs/risks and formulating potential solutions independent and proactively.
· Proficient programming skills in SAS. Skill in R programming is a bonus.
· Experience in oncology/hematology drug development is preferred.
· Extensive 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.
· People management experiences is preferred.
· May require occasional evening and/or weekend commitment.
· Occasional domestic and international travel may be required.
Estimated salary: 265-285k/year
Benefits
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k)
- Paid maternity leave
- Paid paternity leave
- Commuter benefits
- Disability insurance