Senior Manager, Biostatistics

Job Overview 

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Biostatistics. This role will support clinical development programs by providing strategic and technical leadership in the design, analysis, and reporting of clinical studies. The Senior Manager will collaborate with cross-functional teams to ensure statistical integrity, regulatory compliance, and innovative data-driven decision-making throughout the drug development lifecycle. This role will be working as a biostats liaison between Sumitomo Pharma (SMP) and Sumitomo Pharma America, Inc. (SMPA) teams for certain projects. 

Job Duties and Responsibilities 

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Statistical Leadership 

• Lead statistical activities for assigned clinical studies, including protocol development, statistical analysis plan (SAP) creation, and final study reporting. 

• Collaborate with cross-functional teams, including clinical, regulatory, and medical affairs, to ensure study designs meet scientific and regulatory standards. 

• Provide statistical expertise in study design, endpoint selection, sample size determination, and innovative methodologies (e.g., adaptive designs, Bayesian methods). 

Analysis and Interpretation 

• Oversee and validate programming and statistical analyses conducted by internal or external teams. 

• Interpret and communicate statistical findings to non-statistical audiences, including senior leadership, regulatory agencies, and external stakeholders. 

• Prepare and present study results for regulatory submissions, publications, and internal decision-making. 

Global Collaboration 

• Work closely with SMPA teams and collaborate with counterparts at Sumitomo Pharma (SMP) in Japan on global projects, ensuring alignment on statistical methodologies, regulatory strategies, and data analyses. 

• Participate in joint meetings and initiatives to harmonize processes and share best practices across regions. 

Regulatory and Compliance 

• Ensure statistical deliverables comply with regulatory guidelines (FDA, EMA, ICH, etc.) and company SOPs. 

• Contribute to the preparation of regulatory submissions, including briefing documents, responses to agency queries, and integrated summaries of safety and efficacy (ISS/ISE). 

Team Collaboration and Development 

• Mentor and guide junior biostatisticians and statistical programmers. 

• Work closely with data management, clinical operations, clinical research, and external vendors to align statistical requirements with operational deliverables. 

• Stay current on advancements in biostatistics, regulatory requirements, and industry trends to bring innovative solutions to SMPA. 

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Key Core Competencies 

Technical Skills 

• Proficiency in statistical programming languages such as SAS and R. 

• Strong understanding of statistical methodologies and clinical trial design. 

• Knowledge of CDISC standards (SDTM, ADaM) and data visualization tools. 

Soft Skills 

• Excellent verbal and written communication skills. 

• Strong problem-solving and critical-thinking abilities. 

• Effective leadership and collaboration skills in a cross-functional team environment. 

Education and Experience 

• Master’s degree in Statistics, Biostatistics, or a related field (Ph.D. preferred). 

• 4+ years of biostatistics experience in the pharmaceutical, biotechnology, or CRO industry. 

• Proven track record of leading statistical activities for clinical trials in various phases (I-IV). 

• Experience with regulatory submissions (e.g., INDs, NDAs, BLAs) and interacting with health authorities. 

• Familiarity with therapeutic areas such as oncology, CNS, urology, or women’s health is a plus. 

The base salary range for this role is $138,400 to $173,000.    Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. 

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed