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About the position
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. The Senior Manager, Biostatistician is responsible for managing and overseeing all aspects of statistical activities, including tasks performed by vendors, interfacing with in-house staff and in establishing and maintaining global standards procedures.
Responsibilities
- Responsible for development of statistical sections of Protocols and statistical analysis plans, and interpretation of statistical analysis results for all active development studies.
- Participate in vendor selection process. Review or create Requests for Proposal; Document specific requirements (e.g. systems, training records, SOPs)
- Participate in presentation/publication and remain highly visible within the scientific community.
- Collaborate with outside Statisticians at CROs in reviewing and approving statistical analysis plans and final analysis results for all development studies.
- Oversee all aspects of statistics tasks performed by vendor: Review CRF, database and dataset structure.
- Responsible for development of Integrated Statistical Analysis Plan and interpretation of integrated statistical analysis results for NDA/BLA/MAA submissions and information requests from HA.
- Ensures cross-study consistency in design and analysis within Clinical Development Plans.
- Provides SAS programming whenever needed and statistical analyses for publications and presentations of secondary study results of clinical trials.
- Provides statistical input on project topics and issues.
- Interface with in-house staff: Participate on Project Teams; Develop and Review protocols, statistical analysis plans, and Clinical Study Reports.
- Work closely with Medical Monitor(s) to review SAP for logic, consistency, and medical appropriateness.
- Reviews protocols, case report forms, and specifications for study analysis data sets, clinical study reports, statistical analysis plans, and submission and publication analyses.
- Support departmental initiatives related to process building/improvement and integration of new technology.
- Coordinate and liaise global procedures, process, and standards.
Requirements
- PhD in Statistics, or Biostatistics.
- PhD with 3+ year of experience or a Master's in Statistics with 8+ years of experience in pharmaceutical and healthcare industry.
- Must have 2+ year of experience in designing studies and analyzing data for clinical trials and/or early phase clinical pharmacology trials.
- Proficient in MS Office Suite.
- Proficient in SAS, and R.
- Experience in Python preferred.
- Familiarity with ICH guidelines (especially E9) and other regulatory guidance.
- Solid understanding of development, regulatory and commercial aspects of drug development.
