Senior Director, Biostatistics, Clinical Development
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG acquired in 2020, is a fully integrated AAV gene therapy company dedicated to developing life-saving medicines that have the potential to cure genetic diseases. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular and metabolic disease indications with a clinical-stage pipeline that includes therapeutics for Pompe disease, Parkinson’s disease, and congestive heart failure, as well as out-licensed clinical indications for hemophilia and Duchenne muscular dystrophy. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, UK, the company has generated hundreds of proprietary third generation AAV capsids and promoters, several of which have entered clinical testing. Founded in 2001 and an early innovator in the gene therapy field, the company holds more than 850 patents in areas such as AAV production and chimeric and self-complementary capsids. Learn more at www.askbio.com.
The Senior Director, Biostatistics, Clinical Development, reporting to VP, Biostatistics, Clinical Development will provide technical leadership and operational oversight for the development of clinical strategies, the design, implementation and reporting of non-clinical, CMC, and clinical development programs and associated studies and clinical trials. This position will participate in close collaboration with the cross functional teams responsible for studies across all phases of drug development and will provide guidance and management to statisticians to ensure high quality and timely deliverables. In addition, this position will support regulatory interactions and serves as the statistical representative in the defense of the company position/approach on statistical issues and drug approvals globally.
- Responsible for all deliverables related to statistical content. Provides guidance and management to statisticians, programmers, and data managers to ensure high quality and timely deliverables.
- Advise and influence senior leadership/functional leads on Biostatistics strategies and functional issues that have a business impact.
- Oversee biostatistics function in CRO’s; manage scope of work and relationships with other external statistician consultants.
- Manages resources, sets priorities, and ensures consistency and adherence to standards.
- Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment.
- Responsible for SAP, data analysis and reporting (CSR). Supports DMC charter and meeting preparation.
- Represent the Company and Biostatistics function in interactions, both in writing and in person, with the FDA, EMA and other Health Authorities.
- Support regulatory submission and interaction, and IND/BLA filings and supports potential partnering requests.
- Become an integral member of cross-functional project teams, provides statistical input to a wide variety of scientific, clinical development and regulatory document types including Clinical Development Plans, protocols, synopses, Investigator Brochures, regulatory submissions and responses, and scientific publications and presentations.
- Develop solutions to statistical and data analysis issues for clinical, regulatory, and commercial teams. Communicates solutions cross-functionally.
- Contribute to creation/maintenance of, and provides training on statistical topics, and departmental SOPs and general standardization efforts.
- Maintain currency of new developments in statistics, drug development, and regulatory guidance.
- Participate in due diligence evaluation of design and clinical trial data of external partnerships opportunities.
- Assist with the Business Development activities at key conferences and industry meetings.
- Support scientific and medical meetings, including, but not limited to, Investigator Meetings, Advisory Boards, DMC, SAB, and other interactions with Key Opinion Leaders.
- Present at industry conferences representing AskBio.
- Participate in vendor evaluation, selection, and management.
Required Education & Experience
- Ph.D. or M.S. in Statistics or related field.
- Have 10+ (or 12+ years for MS) years pharmaceutical experience in a pharmaceutical R&D environment.
Preferred Experience & Skills
- Strong knowledge of clinical trial design concepts, drug regulation, and experience in the management of the statistical functional. Experience with adaptive and Bayesian study designs simulation techniques, as well as experience in rare diseases and/or gene therapy.
- Extensive experience with SAS and/or R.
- Excellent verbal and written communication skills.
- Experience in CRO selection, contracting and management.
- Excellent leadership and interpersonal skills, ability to build credibility and trust inside and outside the Company.