Associate Director, Biostatistics

Sumitomo Pharma • Marlborough, MA

2d • Remote

About The Position

The Associate Director, Biostatistics reports to the Vice President, Biostatistics and serves as the statistical lead for one or more clinical development programs. The role provides strategic statistical leadership across clinical development, including development planning, study design, quantitative decision-making, data analysis, regulatory submissions, and external collaborations. The Associate Director partners with cross-functional leaders to ensure statistical strategies and deliverables are scientifically rigorous, operationally feasible, and aligned with program and regulatory objectives.

The position also provides technical leadership, coaching, and mentorship to statisticians and statistical programmers as appropriate, and contributes to departmental standards, process improvements, statistical governance, and capability development. It is primarily remote, with periodic on-site meetings in the office and domestic and international travel as needed.

Requirements

• PhD in Statistics, Biostatistics, or a related quantitative discipline with at least 5 years of relevant experience, or an MS with at least 8 years of relevant experience, in the pharmaceutical or biotechnology industry.
• Significant experience providing statistical leadership for clinical development programs and clinical trials.
• Experience overseeing CROs, vendors, or external statistical partners.
• Broad and current knowledge of statistical principles, clinical-trial methodology, and their application throughout drug development.
• Strong understanding of applicable regulatory guidance, including ICH guidelines and expectations of FDA, EMA, PMDA, and other health authorities.
• Knowledge of relevant industry standards, including CDISC standards.
• Proficiency in statistical computing using SAS and R.
• Ability to communicate complex statistical concepts and recommendations clearly to technical and non-technical audiences.
• Demonstrated ability to provide strategic leadership, influence cross-functional decisions, and manage multiple priorities in a fast-paced environment.
• Proven ability to collaborate effectively across functions and communicate recommendations to senior leadership.
• Ability to exercise appropriate judgment, show initiative and independence, and handle multiple demands in a fast-paced environment.
• Excellent written and oral communication skills.
• Ability to use a personal computer for extended periods.

Nice To Haves

• Experience with complex trial designs, Bayesian methods, or innovative statistical approaches.
• Experience supporting regulatory interactions and marketing applications.
• Oncology or hematology clinical development experience.

Responsibilities

• Serve as the biostatistics lead for one or more clinical development programs, providing strategic statistical input into clinical development plans, study designs, operational decisions, decision criteria, and analysis strategies.
• Represent Biostatistics on cross-functional program and study teams and ensure statistical considerations are incorporated into key development decisions.
• Lead statistical interactions with regulatory authorities, including planning and preparing briefing documents, responding to regulatory questions, and discussing statistical methodology.
• Author or oversee the development and review of statistical sections of protocols, statistical analysis plans, regulatory submissions, publications, and other scientific documents.
• Interpret study results statistically, communicate benefit-risk considerations, and support data-driven program decisions.
• Identify statistical, operational, and regulatory risks and recommend practical mitigation strategies.
• Oversee CRO and external vendor statistical activities, including scope definition, quality review, timelines, and delivery of statistical outputs.
• Provide technical leadership, coaching, and mentorship to statisticians and statistical programmers, as appropriate.
• Evaluate and apply innovative statistical methods, including Bayesian approaches, adaptive or complex trial designs, and quantitative decision-making methods when appropriate.
• Contribute to departmental standards, process improvements, statistical governance, and capability development.
• Travel domestically and internationally as needed.

Benefits

• Opportunity for merit-based salary increases
• Short incentive plan participation
• 401(k) plan eligibility
• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Disability insurance
• Leaves provided in line with work state
• Flexible paid time off
• 11 paid holidays plus additional time off for a shutdown period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter

What This Job Offers

• Job Type: Full-time
• Career Level: Senior