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Director, Biostatistics

2 weeks, 4 days ago
Anywhere
Full-time
Executive
Data Scientist
Data Science and Analytics
SAP Statistics
Apply Now
Definium Therapeutics

Definium Therapeutics

Definium Therapeutics is dedicated to advancing psychiatry by developing accessible treatments that leverage the therapeutic potential of psychedelic medicine, guided by scientific rigor and a commitment to addressing the root causes of mental health i...

Health Care Providers & Services
51-250
Founded 2019
View All Jobs 15

Description

  • Provide statistical input to clinical development plans for assigned compounds.
  • Collaborate on clinical trial design, including objectives, endpoints, and sample size determination.
  • Author the statistical methods section of protocols and review protocols throughout development.
  • Ensure the accuracy of randomization algorithms and contribute to eCRF design.
  • Own the study statistical analysis plan and table, figure, and listing shells for assigned trials.
  • Manage statistical vendors to implement analysis plans and deliver study results on time and with high quality.
  • Provide statistical support for data monitoring committee activities, interim analyses, clinical study reports, regulatory communications, and publications.
  • Perform statistical analyses using SAS and support validation with the Statistical Programming group.
  • Support data cleaning efforts with Clinical Data Management and other clinical development functions.
  • Contribute to the development of Biometrics SOPs.

Requirements

  • PhD in Statistics or Biostatistics.
  • At least 10 years of experience in pharmaceutical or biotechnology companies.
  • Strong knowledge of clinical trial design across early- and late-phase development, data analysis, and reporting.
  • Proven experience authoring study SAPs and TFL shells and driving cross-functional review to finalization.
  • Extensive experience managing statistical vendors to implement SAPs and deliver results efficiently.
  • Strong experience using statistical computing languages such as SAS for data analysis.
  • Working knowledge of regulatory guidance relevant to clinical trials from design through analysis.
  • Demonstrated ability to collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Data Science, and other functions.
  • Strong organizational and project management skills, with a commitment to continued learning and growth.
  • Excellent interpersonal skills and the ability to communicate effectively in a work-from-home environment.

Benefits

  • Starting base pay range of $224,643.00 to $249,312.00 annually.
  • Additional compensation may include bonus and equity.
  • 100% paid medical, dental, and vision coverage for employees and dependents.
  • 401(k) plan with company match and vesting after the first month of employment.
  • Flexible time off.
  • Generous parental leave.
  • Additional fringe perks.

Interested in this position?

Apply directly on the company website

Apply Now

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