Manager, Biostatistics

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 individual serves as the lead statistician for one or more clinical studies and collaborates with cross-functional teams including Clinical Development, Statistical Programming, Data Management, Clinical Operations, Medical Writing, Regulatory Affairs, and external partners to ensure the successful execution of clinical trials. Key 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 in 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 the preparation of 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 and 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. Professional Experience / Qualifications • MS and 4 yrs of experience within in Statistics, Biostatistics, or a related quantitative discipline or PhD in Statistics, Biostatistics, or a related quantitative discipline. • 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; experience with R is desirable. • 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. • Oncology clinical development experience is preferred. • Experience working with CROs and external vendors is desirable. Competencies • Scientific rigor and strong attention to detail. • Effective written and verbal communication skills. • Ability to communicate statistical concepts to both technical and non-technical audiences. • Strong organizational and project management skills. • Ability to manage multiple priorities in a fast-paced development environment. • Commitment to quality, innovation, and continuous improvement. Travel Requirements: Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed. Mental/Physical Requirements: Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. The base salary range for this role is $127,500.00 - $159,400.00 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 flexible 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. Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law. Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.