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Senior Statistical Analyst

4 weeks ago

Newbury Park, California, United States Actalent Full time

Job Summary

The Senior Statistical Analyst will work closely with cross-functional team members to ensure clinical studies are appropriately planned, have the required statistical power for success, comply with regulatory requirements, and maintain statistical as well as operational integrity throughout the life of the study.

Key Responsibilities

  • Provide statistical guidance, review, and contribution to protocols, SAPs, TFL shells, DMC Charters, SDF specifications, SDTM, and ADaM randomization specifications.
  • Attend meetings and provide statistical input into cross-functional study start-up activities, including CRF development, database specifications review, database development, IVRS specification review, SAP review, TFL shell review, and TFL review.
  • Perform and document QC of primary and key secondary endpoints within ADaM datasets as well as the statistical analyses of these endpoints programmatically.
  • Manage timelines for all statistics-related deliverables by working with the cross-functional team members.

Requirements

  • Masters degree in Statistics/Biostatistics or other subject with high statistical content and at least 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research.
  • PhD degree with 5 years experience.
  • Demonstrated ability in presenting results and defending statistical findings, study design, and analysis to internal audiences, study/product team, and external meetings.
  • Leadership of at least 3 clinical studies/projects end-to-end with minimal oversight.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market.

We are an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.