Director/Associate Director, Biostatistics

Permanent

Penfield Search Partners

Our client is a leader in the Rare Disease area with several marketed products and a rich pipeline of diverse compounds. They are looking for a Director/Associate Director to oversee Biostatistics activities for multiple clinical programs and to drive functional strategy at both the compound and program levels, especially at the late/submission stage. This is a growing department with a strong commitment to cutting-edge science. Statistics in this company is an important, visible function, and in this role you will have the opportunity to contribute your expertise to support compounds in varying stages of development, interact cross-functionally, and have your ideas heard. You will be encouraged to keep up-to-date with current trends in the industry and to employ implementation of creative solutions to a wide array of statistical challenges utilizing both traditional and newer methodologies. This role will sit in the Hematology/Nephrology area and can be located in Boston, PA, CT or San Francisco. (Flex time in office post-pandemic will be considered.)

The Director/Associate Director, Biostatistics will:

  • Independently provide strategic statistical input to drug development including feasibility assessments, development plans, complex study designs, cross-study statistical methodology, interpretations, regulatory submissions and follow up
  • Ensure timely and accurate delivery of statistical designs, analyses, and reports and regulatory submissions
  • Collaborate closely with Medical, Clinical Operations, Safety, and Regulatory to plan and implement clinical studies as part of a larger clinical development plan, and to analyze and interpret clinical study data
  • Produce Biostatistics deliverables
  • Lead and manage team of internal and external Biostatistics and Statistical Programming resources supporting studies and programs for identified therapeutic area(s) or phase(s) of development
  • Ensure accurate, statistically valid deliverables included in protocols, statistical analysis plans, study reports, manuscripts, and regulatory submission documents
  • Coordinate achievement of major statistical deliverables and milestones in collaboration with other functions
  • Provide statistical leadership for preparation of marketing applications (NDA/BLA) to FDA, EMA and other worldwide regulatory agencies
  • Keep abreast of literature/advancements in the field
  • Monitor project progress and ensure proper resource allocation for successful project deliverables against goals and timelines

Desired for the role:

  • PhD in Statistics/Biostatistics and 6 + years of pharmaceutical experience (for AD, more for Director level); Strong MS-level candidates will be considered as well.
  • Comprehensive knowledge of statistical methodology in design and analysis and regulatory requirements relating to clinical development of drugs and biologics
  • BLA/NDA experience including eCTD submissions
  • Working knowledge of major statistical software programs including SAS
  • Knowledge of CDISC requirements for SDTM and ADaM

 

 

Tagged as: Director/Associate Director, Biostatistics

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