Associate Director, Statistical Programming

Summary

Join Neumora, a biopharmaceutical company revolutionizing brain disease treatment, as an Associate Director of Statistical Programming. You will support compounds through clinical development, regulatory filing, and commercialization, collaborating with biostatisticians and data management colleagues. Key responsibilities include ensuring data accuracy, adhering to industry standards, performing statistical analysis, and managing programming deliverables. The role requires extensive SAS programming experience, pharmaceutical data standards knowledge, and strong organizational skills. Neumora offers a comprehensive benefits package including health insurance, retirement plan, paid time off, and various leave options.

Requirements

• B.A. / B.S. with at least 15 years of experience or an M.S. with at least 10 years of experience in using statistical programming to support clinical trials in pharmaceutical/biotech or CRO setting
• Be proficient in statistical computational software such as SAS, including complicated data steps, SAS macro language, and commonly used procedures (e.g., PROC FREQ, PROC REPORT, PROC GLM, PROC MIXED)
• Have rich experience in following pharmaceutical data standards to create post-EDC datasets (STDM and ADaM) and to create DEFINE packages for eDATA submission to support regulatory filing
• Possess strong organizational skills and time management skills
• Be detail-oriented and hold high standards of excellence for work product
• Be effective in delivering in the work-from-home environment
• Possess excellent interpersonal skills, be an effective communicator, and a good team player

Responsibilities

• Hold the primary responsibilities of ensuring the accuracy of post-EDC datasets (SDTM 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 vendors 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
• Follow good programming practices and internal program validation process
• Provide mentorship and support to junior level statistical programmers

Preferred Qualifications

• Have experience with Python to integrate study-specific details with existing files to assist with periodic data review
• Have experience managing junior statistical programmers to deliver

Benefits

• 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)
• 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
• Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability
• Discretionary year-end bonus