Director, Biostatistics

Location: Remote

Department: Biometrics

What You’ll Do: 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.

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.

Qualifications:

• PhD in biostatistics or related discipline with 7+ years, or Masters 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. Familiarity with CNS endpoints and associated analysis methodologies highly desirable.
• 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 CROs.
• Excellent verbal and written communication skills; Ability to communicate statistical information to non-scientists, willingness to educate internal team.

Location: This is a hybrid position with three days per week onsite at our office in Burlington, MA.