Director, Biostatistics - Clinical Operations

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July 2

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Asklepios BioPharmaceutical, Inc. (AskBio)

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Asklepios BioPharmaceutical, Inc. (AskBio) is a leading gene therapy company focused on developing treatments for debilitating genetic diseases. Wholly owned by Bayer AG, AskBio specializes in adeno-associated virus (AAV)-based gene therapies aimed at treating various neuromuscular, central nervous system, cardiovascular, and metabolic diseases. One of their notable developments is AB-1003 (LION-101), which has received FDA rare pediatric disease and orphan-drug designations for treating limb-girdle muscular dystrophy type 2I/R9. AskBio is dedicated to advancing genetic medicine, with a robust portfolio of clinical programs designed to bring innovative therapeutic options to patients worldwide.

501 - 1000 employees

Founded 2001

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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 CRO’s; 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 • Represent 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, and IND/BLA filings and supports potential partnering requests. • Becomes 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. • 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, and 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 partnerships opportunities as needed. • Assists with the Business Development activities at key conferences and industry meetings. • Supports scientific and medical meetings, including, but not limited to, Investigator Meetings, Advisory Boards, DMC, SAB, and other interactions with Key Opinion Leaders. • Presents at industry conferences representing AskBio. • Participates in vendor evaluation, selection, and management.

🎯 Requirements

• Ph.D. or M.S. in Statistics or related field. • Have 10+ years pharmaceutical experience in a pharmaceutical R&D environment. • Knowledge of Heart Failure and Cardiovascular programs • 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.