Senior Director, Biostatistics, Clinical Operations

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

3d•Hybrid

About The Position

AskBio Inc., a subsidiary of Bayer AG, is a gene therapy company focused on developing life-saving medicines. The company has a portfolio of clinical programs in various disease areas and utilizes proprietary manufacturing processes and genetic elements. AskBio's vision is to pioneer science for transformative molecular medicines, and its mission is to lead innovative science and drive clinical outcomes to transform lives. The company operates with principles of advancing innovative science, bringing transformative therapeutics to patients, and providing an environment for employee growth. Its values include being a pioneer, cultivating collaboration, embracing responsibility, raising the bar, and acting with uncompromising integrity.

Requirements

Ph.D. or M.S. in Statistics or a related field.
10+ years of pharmaceutical experience in a pharmaceutical or biotech R&D environment.
Knowledge of cardiovascular, metabolic, kidney, CNS, and/or rare disease programs.
Previous experience preparing and submitting New Drug Applications to regulatory agencies.
Strong knowledge of design of experiments, clinical trial design concepts or CMC statistics, drug regulation, and management of the statistical function.
Extensive experience with SAS and/or R.
Excellent communication skills.
Experience in CRO selection, contracting, and management.
Excellent leadership and interpersonal skills, with the ability to build credibility and trust inside and outside the Company.

Nice To Haves

Experience with adaptive and Bayesian study design simulation techniques.
Experience in rare diseases and/or gene therapy.

Responsibilities

Responsible for all deliverables related to statistical content.
Provide guidance and management to statisticians, programmers, and data managers to ensure high-quality and timely deliverables.
Advise and influence senior leadership and functional leads on biostatistics strategies and functional issues that have a business impact.
Oversee the biostatistics function at CROs and manage scopes of work and relationships with external statistical consultants as needed.
Manage resources, set priorities, and ensure consistency and adherence to standards.
Collaborate on protocol development, including study design, endpoint selection, and power and sample size assessments.
Take responsibility for statistical analysis plans, data analysis, and clinical study report content.
Support Data Monitoring Committee charters and meeting preparation.
Represent the Company and the Biostatistics function in written and in-person interactions with the FDA, EMA, and other health authorities.
Support regulatory submissions and interactions, including IND and BLA filings, and support potential partnering requests.
Serve as an integral member of cross-functional project teams and provide statistical input to clinical development plans, protocols, synopses, investigator brochures, regulatory submissions and responses, scientific publications, and presentations.
Develop solutions to statistical and data analysis issues for clinical, regulatory, and commercial teams and communicate solutions cross-functionally.
Contribute to the creation and maintenance of departmental SOPs and standardization efforts, and provide training on statistical topics.
Maintain current knowledge of developments in statistics, drug development, and regulatory guidance.
Participate in due diligence evaluations of study designs and clinical trial data for external partnership opportunities as needed.
Assist with business development activities at key conferences and industry meetings.
Support scientific and medical meetings, including investigator meetings, advisory boards, DMCs, SABs, and interactions with key opinion leaders.
Present at industry conferences representing AskBio.
Participate in vendor evaluation, selection, and management.