Kyowa Kirin, Inc.- U.S. - Princeton, NJ
posted 7 days ago
Full-time - Senior
Princeton, NJ
Wholesale Trade Agents and Brokers
About the position
The Senior Manager, Biostatistician, is responsible for managing and overseeing all statistical activities related to real-world evidence studies. This includes collaborating with vendors, interfacing with in-house staff, and ensuring adherence to global standards procedures for products in the global portfolio. The role requires a strong background in biostatistics and experience in the pharmaceutical industry, focusing on evidence generation and statistical analysis.
Responsibilities
- Review or draft statistical sections of protocols and statistical analysis plans, study reports, and interpretation of statistical analysis results for real-world evidence-generation activities.
- Participate in the CRO selection process, including reviewing or creating Requests for Proposal and documenting specific requirements.
- Draft presentations and publications from evidence-generation activities.
- Collaborate with statisticians at CROs to review and approve statistical analysis plans and final analysis results.
- Oversee all aspects of statistics tasks performed by CRO, including reviewing CRF, database, and dataset structure.
- Ensure appropriate learnings and cross-study consistency in design and analysis within real-world evidence-generation plans.
- Provide SAS programming and statistical analyses for publications and conference presentations of post-hoc analysis results of clinical trials.
- Provide statistical input on project topics and issues.
- Maintain up-to-date knowledge of statistical methods for real-world analytics, including ITC, NMA, MAIC, and RWD analytics.
- Build strong relationships with researchers, opinion leaders, and academia in the field of statistics in real-world studies.
Requirements
- MSc, preferably PhD, in Statistics or Biostatistics.
- 5+ years of experience in the pharmaceutical and healthcare industry with a proven track record.
- Practical experience as a biostatistician with observational studies, including confounding/bias reduction and evidence generation.
- Clinical Research experience working with secondary data systems such as administrative claims, EHR, and disease/drug registries.
- Experience in publication support as a biostatistician or as part of the author team in a manuscript.
