Sunovion Senior Manager, Biostatistics in Marlborough, Massachusetts
The Senior Manager, Biostatistics, advises Project Teams on issues of study design, study endpoints, and statistical methods. He/she assures timely completion of the statistical methods section of protocols, sample size estimation, detailed statistical analysis plans, and statistical analysis such as tables/figures/listings for individual study and regulatory submissions. Work may involve oversight of internal or external teams of biostatisticians and statistical programmers.
Job ID: 6574BR
Department: Research & Development
Location: Marlborough, MA
Job Type: Full-time
Summary of Responsibilities: The Senior Manager, Biostatistics, advises Project Teams on issues of study design, study endpoints, and statistical methods. He/she assures timely completion of the statistical methods section of protocols, sample size estimation, detailed statistical analysis plans, and statistical analysis such as tables/figures/listings for individual study and regulatory submissions. Work may involve oversight of internal or external teams of biostatisticians and statistical programmers.
Essential Functions: 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
Minimum Education Requirements: Masters
Experience Required: 5 - 7 Years
Knowledge & Skills (General and Technical): Knowledge and skills (general and technical):
M.S. or Ph.D. preferred in statistics or biostatistics required. 5+ years of previous pharmaceutical or clinical data analysis experience.
Other Requirements (Licenses, Certifications, Specialized Training, Physical or Mental Abilities Required): 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.
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 Sunovion 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 computer for extended periods of time.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sunovion 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.