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Director, Statistical Programming

2 months, 3 weeks ago
Anywhere
Full-time
Lead
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 12

Description

  • Manage a team of statistical programmers supporting projects from dataset creation or validation through data analysis.
  • Serve as lead statistical programmer for regulatory filing efforts and integrated data analyses.
  • Deliver high-quality SDTM and ADaM analysis datasets that meet CDISC standards and ensure derived variable accuracy.
  • Produce high-quality integrated databases to support integrated safety and efficacy analyses.
  • Create high-quality DEFINE packages for SDTM and ADaM datasets.
  • Work closely with biostatisticians to oversee vendor deliverables for quality and timeline.
  • Perform statistical data analysis using SAS programs to support decision-making, regulatory communication, and product commercialization.
  • Conduct independent validation using SAS programs to verify the accuracy of vendor deliverables.
  • Help develop SOPs and processes that govern 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 the pharmaceutical, biotech, or CRO environment.
  • 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, macro language, and common procedures such as PROC Freq, PROC REPORT, PROC GLM, and PROC MIXED.
  • Extensive experience managing statistical vendors to deliver quality work on time and within budget.
  • Strong organizational skills and project and resource management skills.
  • Detail-oriented with high standards for deliverables.
  • Ability to communicate effectively in a work-from-home environment.
  • Strong problem-solving ability, willingness to keep learning, and excellent interpersonal and teamwork skills.
  • Experience supporting CNS clinical trials (preferred).
  • Experience supporting regulatory filing (preferred).

Benefits

  • Starting base salary range of $216,951.00 to $241,497.00.
  • 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.
  • 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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