Associate Director, Statistical Programming

MapLight Therapeutics, Inc.; Burlington (MA); Hybrid; USD 195,000 - 225,000; Full time

Benefits offered by this job

Annual bonus opportunity

Medical, dental, vision insurance

401(K) plan with match

Stock options

Flexible paid time off

Parental leave

Job summary

MapLight Therapeutics, Inc. is looking for an Associate Director of Statistical Programming in Burlington, Massachusetts. This hybrid role requires oversight of SAS programming activities supporting drug development programs and regulatory submissions. Candidates should have at least 8 years of experience in statistical programming in the pharmaceutical sector, strong collaboration skills, and a Master's degree in a relevant field. Compensation ranges from $195,000 to $225,000, with additional benefits including bonuses and health insurance.

Qualifications

• 8+ years of statistical programming experience in the pharmaceutical/biotech industry.
• Proven ability to manage CRO relationships and oversee programmed deliverables.
• In-depth knowledge of CDISC standards for SDTM and ADaM.

Responsibilities

• Oversee SAS programming for datasets, tables, listings, and figures.
• Ensure timely delivery of programming outputs for regulatory submissions.
• Identify and implement new tools and techniques for programming.

Skills

Statistical programming

SAS programming

Regulatory submissions

Collaboration

Data management

Education

Master’s degree in statistics, computer science, or a related field

Tools

SAS

R

Job description

Who We Are

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.

What You’ll Do

Reporting to the Senior Director, Statistical Programming, the Associate Director will provide statistical and clinical data programming expertise to manage statistical programming activities that support drug development programs and regulatory submissions. This role involves overseeing the creation, validation, and delivery of programming deliverables, ensuring compliance with industry standards, and fostering cross‑functional collaboration with biostatistics, data management, clinical, and regulatory teams.

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.
• Establish and maintain 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.

Qualifications

• 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.

Location

This is a hybrid role with three days per week in‑office in Burlington, Massachusetts.

Compensation

Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include 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, and parental leave.

Salary Range

$195,000—$225,000 USD

EEOC Statement

MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.