Director, Statistical Programming

As Director, Statistical Programming, you will provide statistical programming leadership to support pipeline compounds’ clinical development, regulatory filing and commercialization. Reporting to Vice President, Head of Biometrics and Data Science, this role will build and lead the Statistical Programming group while being hands-on and working closely with biostatisticians for data analysis and vendor supervision. This role will support Clinical Data Management group to deliver high quality clinical trial databases and support Data Science group with needed clinical trial data. This role will be responsible for establishing and managing a secured statistical computing environment by collaboration with IT. This role will also be an integral part of multi-functional project teams to provide strategic and technical input as one of the subject-matter-experts.

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

Qualifications and Skills

• 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

The starting base pay range for this position is $202,792.00 - $231,058.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 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!