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Senior Director or Director of Biometrics (onsite San Diego) (Science & Biotech)
San Diego, CA 92122
Recruited by: Ali Henderson | Senior Recruiter | SimulStat Inc. See all my Jobs

  • Hiring Company: SimulStat's client
  • Industry: Science & Biotech
  • Compensation: 165K up to 235K(Sr Dir), relocation available, bonus potential, stock options
  • Expires: Jul 05, 2019
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Job Description

This position will work closely with the Head of Biometrics in identifying project demands and resource needs. This role will be responsible for leading the Biometrics team, which includes programming and data management, to provide strategic, scientific and statistical leadership to the assigned clinical development program(s), with guidance from the Head of Biometrics. This role oversees statistical aspects of assigned projects to ensure that scientific, regulatory and quality requirements are met and that plans are aligned with development goals. The incumbent will collaborate with cross-functional teams composed of internal and/or external experts. This role will contribute to the overall efficiency and best practice running of the Biometrics Department.



Responsibilities:

• Represent the statistics 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 team and external vendor to identify statistical issues, and to propose and implement solutions.

• Provide statistical and strategic input in support of study reports, regulatory documents, publications, and other internal or external requests. Perform statistical analyses as needed.

• Prepare, review and/or approve SAPs, case report forms, clinical DB specifications, validation plans, TLFs, reporting and analysis datasets specifications, and supporting documentation.

• Provide statistical 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 in the support of program strategy. Develop new or leverage existing statistical methodologies to convert data into information to enable decision making.

• Contribute to the professional development of Biometrics personnel though direct management, conducting trainings, or coaching.



Requirements:

• M.S. in Statistics/Biostatistics is required, Ph.D. is preferred.

• 8+ years of relevant experience in the biopharmaceutical industry.

• Hands-on experience in all tasks of a Lead Statistician (at least 4 years), including late stage drug development, submissions, and Health Authority interactions. Experience with disease registries is a plus.

• Vendor and matrix management experience.

• In-depth knowledge of the drug development process, from early to late stage. Experience in orphan or rare diseases is preferred.

• Strong 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.

• 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 preferred.

• Ability to handle multiple tasks with competing timelines.

• 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%)