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Associate Director, Biostatistician

Princeton, New Jersey

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 Associate Director, 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.

Essential Functions:

Statistical Activities
•    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.

Internal Collaboration
•    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.

Requirements:

Education
MS in Biostatistics, Statistics or closely related discipline. Ph.D. highly preferred.

Experience
•    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.

Technical Skills
•    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. 

Working Conditions:

Requires up to 10% domestic and international travel

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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