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Director, Statistical Programming

1 day, 17 hours ago
Anywhere
Full-time
Executive
Data Scientist
Data Science and Analytics
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 18

Description

  • Manage a team of statistical programmers supporting assigned projects from dataset creation or validation through data analysis.
  • Serve as lead statistical programmer for regulatory filings and integrated data analyses, ensuring all data requirements are met.
  • Deliver high-quality SDTM and ADaM analysis datasets that comply with CDISC standards and accurately reflect derived variables.
  • Produce high-quality integrated databases to support integrated safety and efficacy analyses.
  • Create high-quality DEFINE packages for SDTM and ADaM for clinical trials and integrated databases.
  • Work closely with biostatisticians to oversee vendor deliverables for quality and timelines.
  • Perform statistical data analysis using SAS to support decision-making, regulatory communication, and drug product commercialization.
  • Independently validate vendor deliverables using SAS to ensure accuracy.
  • Help develop SOPs and process standards governing statistical programming activities.

Requirements

  • Master’s degree in Biostatistics, Statistics, Computer Science, or a related field.
  • At least 15 years of experience using statistical programming to support clinical trial data analysis in pharmaceutical, biotech, or CRO environments.
  • Experience building and leading statistical programming teams across programs with competing priorities.
  • Deep understanding of data standards and experience creating DEFINE packages to support regulatory filing.
  • Proficiency in SAS, including complex data steps, SAS macro language, and procedures such as PROC Freq, PROC REPORT, PROC GLM, and PROC MIXED.
  • Extensive experience managing statistical vendors for quality, speed, and budget adherence.
  • Strong organizational, project management, and resource management skills.
  • Detail-oriented with high standards for Statistical Programming deliverables.
  • Ability to communicate effectively in a work-from-home environment.
  • Strong problem-solving ability, a commitment to continuous learning, and excellent interpersonal and teamwork skills.
  • Preferred: experience supporting CNS clinical trials.
  • Preferred: experience supporting regulatory filing.

Benefits

  • Starting base pay range of $216,951 to $241,497.
  • Additional compensation may include bonus and equity.
  • 100% paid medical, dental, and vision coverage for employees and dependents.
  • 401(k) program with company match and vesting after the first month of employment.
  • Flexible time off.
  • Generous parental leave.
  • Other fringe perks are included.

Interested in this position?

Apply directly on the company website

Apply Now

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