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: MapLight is looking for an experienced and resourceful Senior Director, Biostatistics.Reporting to the Vice President, Head of Biometrics, the SeniorDirector, Biostatistics will be responsible for all statistical aspects of assigned clinical development programs supporting clinical trials. This is a strategic and hands-on role where you will work with internal and external cross-functional study teams, support interactions with Health Authorities, and manage CRO for statistical related deliverables. Responsibilities: Provide statistical and strategic input to study design, protocol development, sample sizepower calculation, author statistical section of the protocol.Responsible for the development of study SAP, including providing guidance to CRO biostats and programming team, review and approval of specification for derived variables and statistical procedures, table figurelisting shells.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. Represent biostatistics in meetings or teleconferences with Health Authorities.Identify CROvendor requirements and participate in the evaluationselection of analytical vendors. 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.Qualifications:PhD in biostatistics or related discipline with 10+ years, or Master's Degree with 15+ years of experience in the pharmaceutical or biotech industry.Demonstrated ability and experience in the design, analysis and reporting of clinical -depth knowledge of design consideration, familiarity with CNS endpoints and associated analysis methodologies highly desirable.Experience leading NDAs, MAAs or other regulatory submissions.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.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.