Manager, Biostatistics

Sumitomo Pharma • Marlborough, MA

4d • Remote

About The Position

The Manager, Biostatistics (Oncology) provides statistical leadership and support for oncology clinical development programs, from protocol development through clinical study reporting and regulatory submission. The role serves as lead statistician for one or more clinical studies and works with cross-functional teams—including Clinical Development, Statistical Programming, Data Management, Clinical Operations, Medical Writing, Regulatory Affairs, and external partners—to support successful trial execution.

The position is primarily remote, with periodic on-site meetings in the office, and may require domestic and international travel. It involves working in a fast-paced environment with multiple demands, exercising appropriate judgment, and demonstrating initiative and independence. The role requires using a personal computer for extended periods.

Requirements

• A master's degree and 4 years of experience in Statistics, Biostatistics, or a related quantitative discipline, or a PhD in one of these fields.
• Strong understanding of statistical principles and clinical trial methodology.
• Working knowledge of FDA, EMA, PMDA, ICH, and other applicable regulatory guidelines.
• Familiarity with CDISC standards, including SDTM and ADaM.
• Experience supporting the design, analysis, and reporting of clinical trials.
• Proficiency in SAS programming.
• Strong analytical, problem-solving, and communication skills.
• Ability to work effectively in a cross-functional team environment.
• Experience contributing to protocols, SAPs, CSRs, and regulatory submission documents.
• Scientific rigor and strong attention to detail.
• Ability to communicate statistical concepts to technical and non-technical audiences.
• Strong organizational and project management skills, including the ability to manage multiple priorities in a fast-paced development environment.
• Commitment to quality, innovation, and continuous improvement.
• Ability to use a personal computer for extended periods.
• Ability to travel domestically and internationally as needed.

Nice To Haves

• Experience with R.
• Oncology clinical development experience.
• Experience working with CROs and external vendors.

Responsibilities

• Serve as lead statistician for one or more oncology clinical studies.
• Provide statistical input into study design, endpoint selection, sample size determination, randomization methodology, and analysis strategy.
• Contribute to the development and review of clinical study protocols.
• Author and review Statistical Analysis Plans (SAPs).
• Collaborate with Statistical Programming on the development and review of analysis datasets, tables, listings, and figures (TLFs).
• Review statistical outputs and ensure the quality, consistency, and accuracy of study deliverables.
• Interpret study results and communicate findings to multidisciplinary project teams.
• Contribute to Clinical Study Reports (CSRs), abstracts, publications, and regulatory documents.
• Support regulatory submissions and responses to health authorities.
• Collaborate with CRO statisticians and programming teams to ensure timely, high-quality deliverables.
• Ensure compliance with regulatory requirements, company procedures, and industry standards.
• Participate in departmental initiatives to improve statistical processes and standards.
• Provide technical guidance and mentoring to junior statisticians as needed.

Benefits

• Opportunity for merit-based salary increases.
• Short incentive plan participation.
• Eligibility for a 401(k) plan.
• Medical, dental, vision, life, and disability insurance.
• Leaves provided in line with the employee's 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: Manager