Director, Biostatistics

Permanent

Penfield Search Partners

Our client is an emerging force in the Rare Disease area, with promising therapies addressing unmet medical needs in Hematologic disorders, Cancer and Rare Immune diseases. The Director of Biostatistics, reporting to VP of Biometrics and Data Sciences, will work with Early Clinical research teams, Clinical Development teams, and Medical affairs in Supporting clinical development programs and evidence generation activities. 

  • Effectively promote innovation in Biostatistics and in cooperation with peers across all functions
  • Identify productive new technological initiatives/directions such as platform trial design, synthetic controls, applications of real world data
  • Manage and optimize resources (budgets, staff, technology, etc.) for achievement of all goals and objectives
  • Lead and mentor junior team members
  • Represent statistical function to work with Health Authorities and Key Opinion Leaders as needed
  • Provide strategic and technical input into drug development plan; work with cross-functional team to design and operationalize clinical studies; provide statistical input in the evaluation, interpretation and preparation of study results
  • Be accountable and responsible for statistics deliverables such as statistical analysis plans, clinical study reports, protocols, TLGs, publications, congress presentations etc.
  • Select, manage, supervise CROs

Please have:

  • PhD in Biostatistics, Statistics or closely related discipline
  • 5 years of experience in the support of clinical studies in a pharmaceutical or biotech industry setting
  • Comprehensive and detailed knowledge of statistical experimental design, analysis and clinical trial requirements
  • Demonstrated proficiency with statistical software such as R, SAS
  • Proficient in the management and statistical analysis of data obtained from clinical trials
  • Experience with Immunology, Hematology and or Oncology studies preferred
  • Experience with NDA/MAA submissions
  • Understanding of FDA/EU statistical guidelines; experience interacting with regulators
  • Strong project management and contract negotiation skills with outside vendors; ability to efficiently manage multiple CROs
  • Understanding of other disciplines such as Data Management, Clinical Operations, Clinical Science, Regulatory Affairs and Drug Safety
  • Understanding of the application of real world data for clinical trial development
  • Ability to be flexible and adapt quickly to the changing needs of the organization
  • Strong interpersonal and effective communication (oral and written) skills

 

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