Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.
Summary:
The Senior Manager, Biostatistician, is responsible for managing and overseeing all aspects of statistical activities for real-world evidence studies, including tasks performed by vendors, interfacing with in-house staff, and maintaining global standards procedures supporting products in the global portfolio.
Essential Functions:
Statistical Activities
• As a core member of the real-world study team, responsible for reviewing or drafting statistical sections of protocols and statistical analysis plans, study reports, and interpretation of statistical analysis results for all real-world evidence-generation activities.
• Participate in the CRO selection process. Review or create Requests for Proposal; Document specific requirements (e.g., systems, training records, SOPs).
• Participate in the drafting of presentations and publications from evidence-generation activities.
• Appropriately collaborate with statisticians at CROs in reviewing and approving statistical analysis plans and final analysis results for all evidence-generation activities.
• Oversee all aspects of statistics tasks performed by CRO: Review CRF, database, and dataset structure.
• Ensures appropriate learnings and cross-study consistency in design and analysis within real-world evidence-generation plans.
• Provides SAS programming whenever needed and statistical analyses for publications and conference presentations of post-hoc analysis results of clinical trials.
• Provides statistical input on project topics and issues.
• Maintain up-to-date knowledge of statistical methods for real-world analytics to be an in-house expert on the topic, including ITC, NMA, and MAIC, as well as RWD analytics, prospective and retrospective study designs
• Build strong positive relationships with researchers, opinion leaders, and academia in the field of statistics in real-world studies.
Job Requirements:
Education
MSc, preferably PhD, in Statistics or Biostatistics
Experience
5+ years of experience with expertise and a proven pharmaceutical and healthcare industry track record. Practical experience as a biostatistician with observational studies (experience in participating in and executing projects aimed at confounding/bias reduction, experience in generating evidence in collaboration with non-data experts, etc.). Clinical Research experience working with secondary data systems (e.g., administrative claims, EHR, disease and/or drug registries). Experience in publication support as a biostatistician or having joined the author team as a biostatistician in a manuscript.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.
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