Associate Director, Biostatistics

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 statistical results, offering statistical expertise, and participating in presentations and publications. Collaboration with project teams and harmonizing global procedures are also key aspects of this role. The ideal candidate will possess a strong background in biostatistics, extensive 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

Hybrid #remote