Associate Director, Biostatistician

Summary

Join Kyowa Kirin as an Associate Director, Biostatistician and lead statistical activities for NDA/BLA/MAA submissions. You will develop statistical analysis plans, manage collaborations with vendors, and ensure data integrity across clinical development studies. Responsibilities include interpreting results in a regulatory context, offering statistical expertise, and participating in presentations and publications. Collaboration with project teams and harmonizing global procedures are key aspects of this role. The position requires a strong background in biostatistics, experience in clinical trials, and proficiency in SAS programming.

Requirements

• MS in Biostatistics, Statistics or closely related discipline
• Ph.D. in Statistics with a minimum of five (5) years of experience or a Master’s in Statistics with a minimum of ten (10) years of experience within the biotech or pharmaceutical industry
• Minimum four (4) years of experience in designing studies and analyzing data for clinical trials and/or early phase clinical pharmacology trials
• Proficient with SAS programming and other statistical software (e.g., R, Python, etc.,)
• Familiarity with ICH guidelines (especially E9) and other regulatory guidance
• In-depth understanding of development, regulatory and commercial aspects of drug development
• Strong written, verbal, and presentation skills, with the ability to effectively communicate complex concepts to diverse audiences
• Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations

Responsibilities

• Lead the development of integrated statistical analysis plans for NDA/BLA/MAA submissions and responses to health authorities' (HA) information requests. Interpret and analyze results in a regulatory context
• Responsible for development of statistical sections of Protocols and statistical analysis plans, and interpretation of statistical analysis results for all active development studies
• Manage collaboration with Contract Research Organizations (CROs) and other vendors. Review, approve, and ensure the accuracy of statistical analysis plans, CRFs, and dataset structures. Ensure statistical tasks are performed to a high standard
• Ensure consistency across multiple clinical development studies in statistical design and analysis, contributing to the integrity and cohesion of Clinical Development Plans (CDPs)
• Offer statistical expertise on project-related topics and resolve complex statistical challenges, ensuring data integrity and study goals are met
• Participate in presentation/publication and remain highly visible within the scientific community
• Provides SAS or R programming whenever needed and statistical analyses for publications and presentations of secondary study results of clinical trials
• Engage in the vendor selection process, reviewing and creating Requests for Proposals (RFPs), defining specific vendor requirements (systems, SOPs, training records), and ensuring alignment with project needs
• Actively participate on Project Teams; Develop and Review protocols, statistical analysis plans, and Clinical Study Reports; Work closely with Medical Monitor(s) to develop and review SAP for logic, consistency, and medical appropriateness
• Review and provide expert input on study documents, including protocols, case report forms (CRFs), data set specifications, CSRs, and SAPs, ensuring they meet scientific, statistical, and regulatory standards
• Contribute to departmental initiatives focused on process building, process improvement, and the integration of new technologies to enhance efficiency and consistency across the organization
• Liaise and coordinate efforts to harmonize global procedures, processes, and standards, ensuring consistency and adherence to best practices across international teams and studies

Preferred Qualifications

Ph.D. highly preferred

Benefits

• Requires up to 10% domestic and international travel
• Hybrid #Remote