Director Biostatistics, Clinical Operations

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life‑saving medicines and changing lives. Position Summary The Director, Biostatistics, provides 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. He/she participates in close collaboration with the cross functional teams responsible for studies across all phases of drug development. He/she provides guidance and management to statisticians to ensure high quality and timely deliverables. He/she also supports regulatory interactions and serves as the statistical representative in the defense of the company’s position/approach on statistical issues and drug approvals globally. Responsibilities 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. Advises and influences senior leadership/functional leads on Biostatistics strategies as well as functional issues that have a business impact. Oversees the biostatistics function in CROs; manages scope of work and relationships with other external statistician consultants as needed. 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. Represents the Company and Biostatistics function in interactions, both in writing and in person, with the FDA, EMA and other Health Authorities. Supports regulatory submission and interaction, i.e., IND/BLA filings and supports potential partnering requests. Becomes an integral member of cross‑functional project teams, providing 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. Develops solutions to statistical and data analysis issues for clinical, regulatory, and commercial teams. Communicates solutions cross‑functionally. Contributes to creation/maintenance of, and provides training on, statistical topics, departmental SOPs and general standardization efforts. Maintains currency of new developments in statistics, drug development, and regulatory guidance. Participates in due diligence evaluation of design and clinical trial data of external partnership opportunities as needed. Assists with the Business Development activities at key conferences and industry meetings. Supports scientific and medical meetings, including Investigator Meetings, Advisory Boards, DMC, SAB, and interactions with Key Opinion Leaders. Presents at industry conferences representing AskBio. Participates in vendor evaluation, selection, and management. Qualifications Ph.D. or M.S. in Statistics or a related field. 10+ years of pharmaceutical experience in a pharmaceutical R&D environment. Knowledge of Heart Failure and Cardiovascular programs. Previous experience in the preparation and submission of New Drug Applications to regulatory agencies. Strong knowledge of design of experiments, clinical trial design concepts, or CMC statistics, drug regulation, and experience in the management of the statistical function. Experience with adaptive and Bayesian study designs, simulation techniques, as well as experience in rare diseases and/or gene therapy preferred. Extensive experience with SAS and/or R. Excellent 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. AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. #J-18808-Ljbffr AskBio Inc.