Director Biostatistics

Job Title: Director Biostatistics

Job Number: 35313

Location: Remote, 

Job Description

The Program Lead/Director Biostatistics will report to the Senior Director of Biostatistics, serving as an important leader within the organization. The Director of Biostatistics will lead all biostatistics activities for programs, including utilizing the application of innovative quantitative approaches to designs and analysis of trials and clinical development programs. In addition, the Director of Biostatistics will collaborate with Biometrics leadership and the technology team, supporting the development and implementation of tools for clinical trial design and simulation.

Responsibilities

• Lead the statistical strategy and technical activities by driving all statistical activities related to study design, study delivery, data interpretation, and regulatory submissions
• Develop study designs to advance the molecule’s clinical development plan, lead to regulatory approval, and support patient access. 
• Drive the quantitative evaluation of study designs, clinical development paths, and go/no-go criteria through simulation studies. 
• Collaborate with cross-functional teams on the development of regulatory documents and attend regulatory meetings.
• Lead all aspects of statistical reporting and ensure compliance around data submission guidelines, including review and/or authoring of protocols, statistical analysis plans, topline study results, clinical study reports and publications.
• Oversee CRO/Vendor activities to ensure GCP compliance, ensure all work is carried out in strict accordance with the relevant protocols
• Collaborate with Biometrics leadership and the technology team, supporting the development and implementation of tools for clinical trial design and simulation.

Required Skills

• M.S. or Ph.D. in Statistics or Biostatistics
• Experience in the pharmaceutical and/or biotechnology industry
  • At least 8 years’ relevant experience in the pharmaceutical and/or biotechnology industry for candidates holding an M.S. or 6 years’ relevant experience for candidates holding a Ph.D.
• Deep understanding of the statistical designs and methods for early and/or late phase development programs.
• A passion for quantitative decision making with experience evaluating clinical trial designs and clinical development decision criteria via simulation.
• Expertise in either frequentist or Bayesian approaches to study design and decision making.
• Ability to effectively communicate the results of complex statistical analyses and simulations to cross functional colleagues
• Study/program execution experience:
  • Extensive experience leading the statistical execution of multiple clinical trials as either a program lead or indication lead. Detailed understanding of protocol development, SAP development, SDTM/ADaM and TFL development, and clinical study reporting is required. 
• Regulatory experience:
  • Deep understanding of biostatistics regulatory requirements and guidelines. Significant prior experience interacting with health authority agencies such as FDA and EMA. Prior experience contributing to an NDA/BLA is required. 
• Experience utilizing statistical software for design and analysis of clinical trials (e.g., SAS, R, EAST, FACTS)
• Proficient R programming skills are required. Expert R programming skills are preferred.