This role will provide statistical programming leadership to support compounds at different stages, including clinical development, regulatory filing, and commercialization. Reporting to the VP, Head of Biometrics, this role will build and lead the Statistical Programing group, will be hands-on and work closely with biostatisticians and vendors for data analyses, and will support the Clinical Data Management group to deliver high quality databases. This role will also be an integral part of multi-functional project teams to provide strategic and technical input as one of the SMEs.

Responsibilities:

• Build and lead the Statistical Programming group within Neumora’s Biometrics department
• Hold the primary responsibilities of ensuring the accuracy of post-EDC datasets (STDM and ADaM) creation from reviewing specifications to performing independent quality control validation using own SAS programs
• Ensure clinical trial data collection and post-EDC datasets are consistent with industry standards and ready for eDATA submission
• Work closely with biostatisticians using own SAS programs to perform statistical data analysis to support internal decision making, regulatory communication, or drug product commercialization
• Perform independent quality control validation for analytic outputs delivered by statistical vendor or by colleagues in Neumora’s Biometrics team
• Work closely with Clinical Data Management colleagues to produce systematical data reports to support effective clinical trial data review and cleaning
• Work directly with study team members in Clinical Development and Clinical Operations to provide programming to address data-related questions and to support identification of protocol deviations
• Manage study-level programming deliverable timeline in collaboration with study lead biostatistician
• Manage statistical computing environment from folder structure to access control
• Create necessary SOPs or processes governing statistical programming activities, as needed

Qualifications:

• B.A. / B.S. with at least 20 years of experience or an M.S. with at least 15 years of experience in using statistical programming to support clinical trials in pharmaceutical/biotech or CRO environment
• Strong people management with experience building a Statistical Programming group
• Experience managing a team to deliver on competing priorities
• Proficient in statistical computational software such as SAS, including complicated data steps, SAS macro languages, and commonly used procedures (e.g., PROC FREQ, PROC REPORT, PROC GLM, PROC MIXED)
• Experience with Python to integrate study-specific details with existing files to assist with periodic data review is a plus
• Rich experience in following pharmaceutical data standards to create post-EDC datasets (STDM and ADaM) and to create DEFINE packages to support regulatory filing
• Demonstrated problem-solving ability and interest in continued learning
• Strong organizational skills, project management skills, and time management skills
• Detail-oriented and holds high standards of excellence for own work product
• Ability to deliver and communicate effectively in the work-from-home environment

2024 Company benefits include:

• Medical, dental, vision, and life insurance
• 401(k) plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
• Company Equity (New Hire Awards, Annual Awards, ESPP)
• Annual paid time off:
• Accrued Vacation Days: 15 days per year
• Sick Days: 10 days per year
• Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December
• Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability
• Discretionary year-end bonus

The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $217,638-$229,659