Careers

Senior Director, Statistical Programming

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:

MapLight is looking for an experienced and resourceful Senior Director, Statistical Programming.  Reporting to the Head of Biometrics, the Senior Director will provide statistical and clinical data programming expertise and leadership for the function, and will be responsible for developing and maintaining programming infrastructure, processes, and standards; planning and managing programming resources to meet business needs across all clinical programs, and playing a key role in oversight of statistical vendors. The incumbent will also take on the role of Statistical Programming Lead for clinical programs.

 

Responsibilities:

  • Responsible for all aspects of Programming function, including setting up programming environment, establishing processes, monitoring project timelines and effectively managing CROs.
  • Ensures adequate support by programming group for all stages of clinical studies, including review of case report forms, review of statistical analysis plans, development of shells for tables, figures and listings, programming support of data cleaning, ad hoc and exploratory analyses, interim and final analyses, publications, etc.
  • Leads statistical programming efforts for NDA, MAA and other regulatory submissions, including SDTM and ADaM datasets and associated define files, tables/figures/listings for integrated summaries (ISS and ISE), etc.
  • Represents Company as Subject Matter Expert on clinical data submission in meetings with FDA and other regulatory agencies; and provides leadership in addressing clinical data submission questions/comments from FDA and other regulatory agencies.
  • Develops and implements processes (e.g., SOPs and WIs) and standards consistent with regulatory requirements and best industry practice for Programming function.
  • Programming lead ownership for clinical programs as needed. Hand-on programming work in SAS and other programming languages/tools.
  • Establishes and maintains CRO/vendor partnerships.
  • Forecasts and manages Statistical Programming resources to meet current and future business needs.
  • Responsible for recruiting, coaching, mentoring, and performance management of direct reports.

Qualifications:

  • Master’s degree in statistics, computer science or a related field
  • At least 15 years of statistical programming experience in the pharmaceutical/biotech industry with least 5 years of experience in leading/managing a programming team.
  • 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

 

 

MapLight 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.

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