Senior Manager, Biostatistics
Sumitomo Pharma America (SMPA) is focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need spanning psychiatry & neurology, oncology, urology, women’s health, rare disease, and cell & gene therapies. The company’s diverse portfolio includes several marketed products and a robust pipeline of early- to late-stage assets. Building on Sumitomo Pharma’s 125-year legacy of innovation, SMPA leverages proprietary in-house technology platforms and advanced analytics capabilities to accelerate discovery, development, and help bring novel therapies to patients sooner. SMPA is a Sumitomo Pharma company. [For more information, visit Sumitomo-pharma.com]
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Biostatistics. This is a remote based role that will require some travel for meetings. The Senior Manager, Biostatistics advises Project Teams on issues of study design, study endpoints, and statistical methods. Will assure timely completion of the statistical methods section of protocols, sample size estimation, detailed statistical analysis plans, and statistical/clinical study reports for regulatory submissions. This typically involves oversight of internal or external teams of biostatisticians and statistical programmers.
Job Duties & Responsibilities
Produce or oversee the production of protocol development (study design, endpoint selection, statistical methods section) and detailed statistical analysis plans that lead to comprehensive statistical/clinical study reports suitable for regulatory submissions.
Represent the Biostatistics function on Clinical Project Teams for the development of new pharmaceutical products, advising cross-functional partners (e.g., Project Medical Leader, Clinical Pharmacology, Clinical Operations, and Regulatory Affairs) on statistical issues.
Research statistical methods to assure state-of-the-art Statistical Analysis Plans that meet regulatory requirements.
Perform statistical analyses of clinical data as necessary for management decisions, regulatory requests for information, and commercial support.
Key Core Competencies
Strong methodological capabilities, experience with regulatory submissions, project and proposal management experience, and broad drug development experience are relevant qualifications for this position.
Knowledge of statistical software and SAS experience is a requirement.
Education and Experience
M.S. or Ph.D. in statistics or biostatistics required.
Previous pharmaceutical or clinical data analysis experience, 7+ years for MS and 4+ for Ph.D.
Ability to work for extended periods at a computer and occasional travel are required.
The base salary range for this role is $137,500.00 to $180,500.00. 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 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.
Confidential Data:All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
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.
Mental/Physical Requirements: Fast paced environment handling multiple demands. 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.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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