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Principal Biostatistician

  • Location: United States of America
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 28 days ago

  • Sector: Life Sciences
  • Contact: Alicia Licht
  • Expiry Date: 28 September 2022
  • Job Ref: JN -042022-469529

Sponsor Oncology client is looking for a remote Sr/Principal level Biostatistician for their growing team!

Responsible for:

  • Responsible for oversite of the clinical trial study design and development of statistical analysis plans (SAP)
  • Leads coordination of functional teams to develop custom data models, algorithms, and monitor outcomes.
  • May perform data review & statistical analyses; coordinate/oversee statistical outputs
  • Provide input on EDC system development including but not limited to database design, CRF design, validation checks & key data
  • Leads internal and external partners to establish, align and confirm data management expectations
  • Responsible for the development and writing of statistical sections for integrated reports and statistical reports
  • May review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency.
  • Ensures content and integration requirements for eCRF and other data collection tools are met.
  • Ensure conventions and quality expectations for clinical data are maintained for dataset content and structure
  • Ensure the proper execution of SAS programming deliverables
  • Understand and apply regulatory guidelines/developments and industry standards/best practices on statistics and SAS programming
  • Maintain statistical, clinical, and therapeutic acumen in clinical research through education, programs, lectures and publications

Qualifications (Education & Experience):

· Minimum of 5 years of experience in statistics in a CRO/Pharma setting

· Master's or PHD in statistics or biostatistics.

· Excellent knowledge of RAVE, CDISC and SAS under FDA/EMA requirement

· Excellent written and verbal communication skills for coordinating across teams.

· Oncology experience a plus!