MapLight Therapeutics
biotech
AssociateDirector,StatisticalProgramming
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“Associate Director, Statistical Programming at MapLight Therapeutics. Skills: Statistical Programming, SAS programming, CDISC standards, regulatory submissions. provide statistical and clinical data programming expertise. manage statistical programming activities”
Industry & Context.
resolve programming issues and optimize processes
What They're Looking For.
Must Have
Master's degree in statistics, computer science or a related field, At least 8 years of statistical programming experience in the pharmaceuticaliotech 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 (NDALA, MAA), 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, interact effectively in a fast-paced team environment
Nice to Have
knowledge of R and R Shiny desirable
What You'll Do.
provide statistical and clinical data programming expertise
manage statistical programming activities
overseeing the creation
and delivery of programming deliverables
ensuring compliance with industry standards
development and validation of SAS programs to generate datasets (SDTM
Ensure the timely and high-quality delivery of programming outputs
Ensure all programming activities align with industry standards (CDISC
EMA) and internal SOPs
Programming lead for clinical programs
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
Partner with biostatistics
and clinical operations to resolve programming issues and optimize processes
Identify and implement new tools
and processes to improve efficiency and quality in statistical programming
How You'll Work.
Team & Collaboration
fostering cross-functional collaboration with biostatistics, data management, clinical, and regulatory teams; 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; ability to collaborate with a multidisciplinary team
Communication Scope
Excellent written and verbal communication skills; ensuring clear communication
Process & Methodology
manage statistical programming activities, overseeing the creation, validation, and delivery of programming deliverables, Programming lead for clinical programs, manage CRO relationships and oversee programmed deliverables, leading statistical programming function for both early and late phase clinical trials, and regulatory submissions
Full 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. 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. Qualifications: Master’s degree in statistics, computer science or a related field At least 8 years of statistical programming experience in the pharm
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