Associate Director, Statistical Programming

MapLight Therapeutics; 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 non-accrual paid time off

Parental leave

Job summary

MapLight Therapeutics in Burlington, MA is seeking an Associate Director of Statistical Programming to oversee programming for drug development. This hybrid role involves leading statistical programming tasks and ensuring compliance with industry standards. The ideal candidate will have a Master’s degree and at least 8 years in biotech. The position offers a salary range of $195,000 to $225,000, along with additional benefits including bonuses, health insurance, and a 401(k) plan.

Qualifications

• At least 8 years of statistical programming experience in the pharmaceutical/biotech industry.
• Proven ability to manage CRO relationships and oversee programmed deliverables.
• Excellent written and verbal communication skills.

Responsibilities

• Oversee the development and validation of SAS programs for datasets and TLFs.
• Ensure timely delivery of programming outputs for regulatory submissions.
• Act as a liaison between statistical programming and other functions.

Skills

SAS programming

Statistical reporting

CDISC standards knowledge

Communication skills

Education

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

Tools

SAS

R

R Shiny

Job description

Associate Director, Statistical Programming

Burlington, MA

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.
• Program 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: Salary Range $195,000 - $225,000 USD. 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.

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.