Director, Biostatistics

MapLight Therapeutics, a clinical-stage biotech company specializing in central nervous system disorders, is seeking an experienced Director of Biostatistics to join their team in Burlington, MA. This role reports to the Senior Director of Biostatistics and involves leading statistical aspects of assigned clinical projects, collaborating with cross-functional teams, and managing interactions with health authorities.

The Director of Biostatistics will be responsible for providing and validating sample size and power calculations, authoring statistical sections of protocols, and developing study statistical analysis plans (SAPs) and table/figure/listing shells. The role includes overseeing the work of contract research organizations (CROs), ensuring the quality and timeliness of statistical deliverables, and contributing to clinical study reports and publications.

Candidates should possess a PhD in biostatistics or a related discipline with at least 7 years of experience, or a Master's degree with at least 10 years of experience in the pharmaceutical or biotech industry. Demonstrated expertise in the design, analysis, and reporting of clinical trials is essential. Proficiency in statistical programming languages such as SAS and R, along with knowledge of FDA, EMA, and ICH regulations, is required.

The position offers a competitive salary range of $195,000 to $245,000, with additional benefits including an annual bonus opportunity, medical, dental, vision, life and AD&D insurance, short-term and long-term disability coverage, a 401(k) plan with match, stock options, flexible non-accrual paid time off, and parental leave.

MapLight Therapeutics fosters a collaborative and innovative work environment, focusing on cutting-edge technologies to develop effective therapies for psychiatric symptoms. Joining the team provides an opportunity to contribute to meaningful advancements in the treatment of central nervous system disorders.