Executive Director – Biometrics

Executive Director – Biometrics

Requirements

• M.S. in Statistics/Biostatistics is required, Ph.D. is preferred.
• 12+ years of relevant experience in the biopharmaceutical industry.
• Hands-on experience in all tasks of a Lead Statistician (at least 10 years), including late-stage drug development, regulatory submissions, and Health Authority interactions. Experience with disease registries is a plus.

Responsibilities

• Lead the Biostatistics function and provide strategic input and statistical leadership of multiple clinical studies or projects.
• Responsible for the planning and delivery of the Biometrics components required to support the design, analysis, and reporting needs of clinical development projects. Work directly with the project teams and external vendors to identify statistical issues, and to propose and implement solutions.
• Provide statistical leadership and strategic input to study protocols, study reports, regulatory documents, publications, and other internal or external requests. Perform statistical analyses as needed.
• Prepare, review and/or approve study protocols, SAPs, case report forms, clinical DB specifications, validation plans, TLFs, reporting and analysis datasets specifications, and supporting documentation.
• Provide oversight to internal and/or external Biometrics teams to ensure timeliness and quality of deliverables.
• Lead or contribute to the development and maintenance of Biometrics-related SOPs, work practice documents, technical standards, and specification documents.
• Research and apply new statistical approaches as needed. Initiate and drive innovation by implementing relevant innovative designs or analyses in support of program strategy. Develop new or leverage existing statistical methodologies to convert data into information to enable decision making.
• Manage biostatisticians and contribute to the professional development of Biometrics personnel by conducting trainings or coaching.
• Lead or contribute to process improvements within Biometrics.

Preferred Qualifications

• NDA or MAA experience is a must.
• Extensive vendor and personnel management experience.
• Broad and thorough understanding of the drug development process, from early to late stage.
• Experience in orphan or rare diseases is preferred.
• Broad and thorough understanding of statistical principles and clinical trial methodology.
• Broad and thorough understanding of FDA and ICH requirements and industry standards applicable to the design, conduct and analysis of clinical trials, including SDTM, ADaM, and CDISC/eCTD requirements for regulatory submissions.
• Broad experience with data pooling to support Integrated Summary of Safety (ISS)/Integrated Summary of Efficacy (ISE) and periodic reports.
• Extensive experience with study designs, power/sample size computations, (longitudinal) data analysis, and simulations.
• Proficiency in SAS programming to produce ad hoc tables, listings and figures. Experience with other statistical software such as R is strongly preferred.
• Ability to handle multiple tasks with competing timelines and shifting priorities.
• Excellent communication and collaboration skills with internal and external team members. Ability to explain statistical concepts to non-statisticians and to guide study team members in the proper use of statistics.
• Solution oriented, attention to detail, and ability to perform in a high-demand and dynamic working environment.
• Able to travel (up to 20%)