Director, Biostatistics

MapLight Therapeutics•Burlington, MA

1d•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. MapLight is looking for an experienced and resourceful Director, Biostatistics. Reporting to Senior Director, Biostatistics, this role will be responsible for the statistical aspects of assigned clinical projects. This is a hands-on role where you will work with internal and external cross-functional study teams, support interaction with Health Authorities, and manage CRO for statistical related deliverables.

Requirements

PhD in biostatistics or related discipline with 7+ years, or Master's Degree with 10+ years of experience in the pharmaceutical or biotech industry.
Demonstrated ability and experience in the design, analysis and reporting of clinical trials.
Knowledge of design considerations.
Extensive knowledge of FDA, EMA and ICH regulations and industry standards applicable to the design and analysis of clinical trials and regulatory submissions.
Proficient in statistical programming (SAS and R).
Experience with trial design software (e.g., EAST).
Ability to concurrently lead statistical efforts for multiple projects.
Understanding data standards, including SDTM and ADaM.
Adept at overseeing statistical services provided by CRO's.
Excellent verbal and written communication skills; Ability to communicate statistical information to non-scientists, willingness to educate internal team.

Nice To Haves

Familiarity with CNS endpoints and associated analysis methodologies highly desirable.

Responsibilities

Provide/validate sample size/power calculation and author statistical section of the protocol.
Responsible for the development of study SAP and table/figure/listing shells including overseeing CRO’s work.
Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Regulatory and other functions to meet project deliverables and timelines.
Provide statistical and strategic inputs in documents prepared for regulatory interactions.
Provide technical oversight of statistical activities of external vendors to ensure timeliness and quality of analysis data and statistical outputs.
Review and approve key statistical vendor deliverables.
Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results.
Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations.