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Associate Director, Biostatistics

1 month, 1 week ago
Anywhere
Full-time
Lead
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 14

Description

  • Serve as the study biostatistician for assigned clinical trials, from design through analysis and reporting.
  • Provide statistical support for integrated analyses and regulatory filing dossier preparation.
  • Collaborate with cross-functional experts on 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 so study objectives and data collection align.
  • Work with statistical vendors and the internal Statistical Programming team to deliver study results and integrated analyses on time and with high quality.
  • Provide statistical input to clinical study reports, regulatory communications, and publications.
  • Conduct data analyses using SAS programs in collaboration with the internal Statistical Programming team.
  • Partner with Clinical Data Management to support data cleaning activities.

Requirements

  • PhD in Statistics, Biostatistics, or a relevant field with at least 7 years of experience in pharmaceutical or biotechnology companies, or a Master's degree with at least 10 years of experience.
  • Solid statistical knowledge and experience in clinical trial design, data analysis, and reporting across early- to late-phase studies.
  • Experience authoring study SAPs and TFL shells and leading review cycles to reach consensus.
  • Extensive experience managing statistical vendors to implement SAPs and deliver study results.
  • Strong experience using statistical programming 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 an interest in continued learning and growth.
  • Detail-oriented with high standards for work product quality.
  • Strong communication skills and ability to work effectively in a work-from-home environment.
  • Excellent interpersonal skills and ability to work well in a team.
  • Preferred: experience in CNS drug development from clinical trial design through data analysis.
  • Preferred: experience in regulatory filing, including integrated data analysis planning, execution, and submission dossier preparation.

Benefits

  • Starting base pay range of $183,656 to $208,950.
  • Eligibility for additional compensation, including bonus and equity.
  • 100% paid medical, dental, and vision benefits for employees and dependents.
  • 401(k) program 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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