Director, Biostatistics

MapLight Therapeutics, Inc.

Director of Biostatistics leading statistical aspects of clinical projects for a biotech company. Collaborating with cross-functional teams to ensure effective drug discovery in central nervous system disorders.

Posted 7/1/2026full-timeBurlington • Massachusetts • 🇺🇸 United StatesLead💰 $195,000 - $245,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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. 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 CRO's.
Excellent verbal and written communication skills; Ability to communicate statistical information to non-scientists, willingness to educate internal team.

Benefits

Comp & perks

annual bonus opportunity
medical
dental
vision
life and AD&D
short term and long term disability
401(K) plan with match
stock options
flexible non-accrual paid time off
parental leave

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Statistical Analysis Plan (SAP) DevelopmentSample Size/Power CalculationClinical Study Report AuthoringData Standards (SDTM And ADaM)Trial Design Software (EAST)

Soft Skills

Excellent Verbal And Written CommunicationAbility To Educate Non-Scientists