Director, Statistical Programming

Summary

Join MindMed as the Director, Statistical Programming, providing leadership in statistical programming to support clinical development, regulatory filing, and commercialization of pipeline compounds. You will build and lead the Statistical Programming group, working closely with biostatisticians, the Clinical Data Management group, and the Data Science group. Responsibilities include delivering high-quality analysis datasets, DEFINE packages, and performing statistical data analysis. You will manage statistical vendors, build a secure computing environment, and create SOPs. This role requires a Master's degree in a relevant field and 15+ years of experience in statistical programming within the pharmaceutical, biotech, or CRO environment. The starting salary range is $202,792.00 - $231,058.00, with additional compensation including bonus and equity.

Requirements

• Master's Degree in Biostatistics, Statistics, Computer Science or other relevant fields with at least 15 years of experience in using statistical programming to support clinical trial data analysis in pharmaceutical, biotech or CRO environment
• Solid experience of building and leading statistical programming groups to deliver across programs often with competing priorities
• Deep understanding about data standards with rich experience in creating DEFINE packages to support regulatory filing
• Proficient in statistical computational software such as SAS, including complicated data steps, SAS macro languages, and commonly used analysis procedures (e.g., PROC Freq, PROC REPORT, PROC GLM, and PROC MIXED)
• Extensive experience in managing statistical vendor to deliver with quality and speed and within the budget
• Strong organizational skills, project and resources management skills
• Detail-oriented and hold high standards of excellence for Statistical Programming group’s deliverables
• Deliver and communicate effectively in the work-from-home environment
• Strong track record of problem solving with demonstrated interests of continued learning and growth
• Excellent interpersonal skills and a good team player

Responsibilities

• Build and lead Statistical Programming Group within MindMed Biometrics and Data Science organization
• Responsible for delivering high quality analysis datasets (SDTM and ADaM) from meeting CDISC standards to ensuring accuracy of all derived variables for each clinical study
• Responsible for delivering high quality DEFINE packages for SDTM and ADaM for eDATA submission as part of the regulatory filing package
• Work closely with study lead biostatistician to manage vendor’s deliverables from quality to timeline
• Perform statistical data analysis for trial data using own SAS programs as needed to support decision making, regulatory communication or drug product commercialization
• Perform independent validation using own SAS programs to ensure accuracy of statistical vendor’s deliverables from datasets to analytic outputs
• Work closely with Clinical Data Management colleagues to produce systematic data reports to support efficient clinical trial data review and cleaning
• Provide programming support to Clinical Development and Clinical Operations and provide assistance to Data Science group as needed
• Build and manage statistical computing environment to ensure necessary “fire wall” and clear organization from programs to outputs
• Create necessary SOPs or processes governing statistical programing activities

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!