Associate Director, Statistical Programming

MapLight Therapeutics • Burlington, MA

12h • Hybrid

About The Position

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

Requirements

• Master’s degree in statistics, computer science or a related field
• At least 8 years of statistical programming experience in the pharmaceutical/biotech industry
• Proven ability to manage CRO relationships and oversee programmed deliverables.
• Extensive experience in leading statistical programming function for both early and late phase clinical trials, and regulatory submissions (NDA/BLA, MAA)
• Excellent skills in SAS programming and statistical reporting, knowledge of R and R Shiny desirable
• In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements
• Familiarity with FDA and ICH regulations and guidelines
• Excellent written and verbal communication skills, ability to collaborate with a multidisciplinary team and interact effectively in a fast-paced team environment

Nice To Haves

• knowledge of R and R Shiny desirable

Responsibilities

• Oversee the development and validation of SAS programs to generate datasets (SDTM, ADaM), tables, listings, and figures (TLFs) in compliance with CDISC standards.
• Ensure the timely and high-quality delivery of programming outputs for regulatory submissions, clinical study reports, and exploratory analyses.
• Ensure all programming activities align with industry standards (CDISC, ICH, FDA, EMA) and internal SOPs.
• Programming lead for clinical programs as needed. Hand-on programming work in SAS and other programming languages/tools.
• Establishes and maintains CRO/vendor partnerships.
• Act as a liaison between statistical programming and other functions, ensuring clear communication and alignment of goals.
• Partner with biostatistics, data management, and clinical operations to resolve programming issues and optimize processes.
• Identify and implement new tools, techniques, and processes to improve efficiency and quality in statistical programming.

Benefits

• annual bonus opportunity
• medical
• dental
• vision
• life and AD&D
• short term and long term disability
• 401(K) plan with match
• stock options
• flexible non-accrual paid time off
• parental leave

What This Job Offers

• Job Type: Full-time
• Career Level: Manager