Director, Biostatistics

MapLight Therapeutics, Inc.; Burlington (MA); Hybrid; USD 195,000 - 245,000; Full time

Benefits offered by this job

Annual bonus opportunity

Medical, dental, and vision insurance

401(K) plan with match

Stock options

Flexible non-accrual paid time off

Parental leave

Job summary

MapLight Therapeutics, Inc. is seeking an experienced Director of Biostatistics to oversee the statistical aspects of clinical projects. This hybrid role requires a PhD in Biostatistics or related discipline with at least 7 years in the pharmaceutical or biotech industry. Responsibilities include leading statistical designs, collaborating with cross-functional teams, and ensuring the quality of statistical outputs. The position offers competitive compensation ranging from $195,000 to $245,000, along with various benefits including a bonus opportunity and generous leave policies.

Qualifications

• 7+ years of experience in the pharmaceutical or biotech industry required.
• Ability to lead statistical efforts for multiple projects concurrently.
• Familiarity with CNS endpoints and associated analysis methodologies highly desirable.

Responsibilities

• Provide/validate sample size/power calculations for clinical projects.
• Develop study SAP and oversee CRO's work.
• Work with cross-functional teams to meet project deliverables and timelines.
• Author statistical sections of documents for regulatory interactions.

Skills

Design and analysis of clinical trials

Knowledge of FDA, EMA, ICH regulations

Statistical programming (SAS, R)

Communication skills

Understanding of data standards (SDTM, ADaM)

Education

PhD in Biostatistics or related discipline

Master’s Degree with 10+ years of experience

Tools

SAS

R

Trial design software (e.g., EAST)

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 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 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.

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

Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include 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, and parental leave.

Salary Range
$195,000—$245,000 USD

EEOC Statement: MapLight Therapeutics 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.