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Role Description

The Associate Director, Biostatistics role will be responsible for overseeing statistical activities for multiple clinical studies and/or a clinical program, participating in study designs and protocol development, ensuring compliance with SOPs to produce quality and timely deliverables. This individual will participate in departmental and cross-functional technology development and process improvement initiatives. This is a full-time position and can be remote or hybrid (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Responsibilities

• Serve as a lead statistician and manage statistical efforts for multiple clinical studies.
• Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles.
• Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells for tables, figures, and listings.
• Review CRF designs to ensure data collection meets the study objectives and the requirements of statistical analyses.
• Provide statistical input to data monitoring committee (DMC) charters, project management plan, and other study-level documents.
• Work with statistical programmers or CROs to generate tables, figures, and listings.
• Support ongoing safety review and DMC review of the clinical development program/study teams.
• Perform ad hoc and exploratory statistical analyses as needed.
• Contribute to clinical study reports, including authoring of statistical sections and interpretation of the study results.
• Support regulatory submissions as needed.
• Support the preparation of publications, including manuscripts, posters, and oral presentations.
• Accountable for the performance and results at a study level. Ensures the implementation of biostatistics decisions and best practices.
• Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs.

Qualifications

• PhD in statistics or a related field with at least 6 years (or MS with at least 9 years) of relevant clinical trial experience.
• Knowledge of statistical methods for clinical trials.
• In-depth knowledge of FDA, EMA, and ICH regulations and guidelines.
• Experience with BLAs, MAAs, and other regulatory submissions is a plus.
• Proficient in statistical programming (SAS is required and R is a plus).
• Experience with trial design software (e.g., EAST).
• Good communication skills and ability to work with cross-functional study teams.
• Good organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Good analytical and problem-solving skills.
• Positive, outgoing, and collaborative attitude.

Requirements

• Base Salary Range: $183,000 - $221,000.
• This role is eligible for an annual bonus and long-term incentive.
• Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.

Benefits

• Comprehensive health, life, and disability insurance.
• Employer-matched 401(k) plan.
• Lifestyle spending account.
• Flexible time-off + paid holidays and winter shutdown.
• Tuition reimbursement & loan repayment assistance.
• Paid parental leave.
• Generous commuter subsidy.
• And much more.