Working closely with the leaders of NKGen Biotech, the Sr. Director of Biometrics will serve as the lead statistician and is responsible and accountable for all statistical aspects for the assigned compound’s development throughout development phases and regulatory filing activities. This role will provide strategic input in collaboration with other functions in identifying an efficient path to advance pipeline compound(s). The successful candidate is expected to have rich experience in new drug development and regulatory interactions, and have solid statistical knowledge from clinical trial design, data analysis, to result interpretation.
- Ensure overall efficiency and effectiveness in biostatistics, clinical data management and statistical programming function
- Oversee and lead the biometrics function to develop and execute statistical strategy, study design, and analyses for clinical trials and development programs
- Develops and fosters productive relationship across internal functional areas
- Manage CROs regarding statistical activities to ensure timely delivery of quality analysis results and proposed resourced
- Represent NKGen biostatistics in health authorities filing activities
- Establish the functional standard operating procedures, work structure and best practices in biostatistics and statistical programming function
- Continue to build and resource the team, mentors and develops members of the biostatistics organization
- Supervise internal and external biometrics resources to achieve company goals
*The company reserves the right to add or change duties at any time.
Job Qualifications & Skills
- A minimum of 10 years of experience in oncology clinical drug development, Pharmaceutical/Biotech setting
- Experience with analysis of patient reported outcome data.
- Demonstrate skills in the analysis and reporting of clinical trials.
- Experience with integrated summaries of safety and efficacy (ISS and ISE)
- Strong knowledge of clinical trial design concepts, clinical drug development process, statistical methodologies and statistical regulatory requirements including ICH and CDISC.
- Prior experience as statistical representative in interactions with regulatory and health authorities considered a plus.
- Experience in managing, developing, and motivating professionals, including external consultants and contract research organizations
- Experience working in a cross-functional team environment.
Benefits & Perks
- Competitive compensation
- Medical, Dental and Vision Insurance
- Business casual work attire
- Fully stocked kitchen and much more!