Lead Biostatistician - FDA BLA Submission (Clinical Trial Statistical Design)

Lead Biostatistician – FDA BLA Submission (Clinical Trial Statistical Design) This is an exciting opportunity to lead our global Biostatistics efforts. Clinical Trial Statistical Design and BLA Submission Draft accurate, clear and detailed statistical analysis plans (SAPs) and related clinical protocols Work with team /program ADaM and SDTM outputs for FDA BLA Communicate, discuss and interpret (top-line) data and statistical results, including co-development of the clinical study report (CSR) Develop, apply and maintain computer programs for data analysis, e.g. SAS and R as needed What We Look For Ph.D., Master's, or bachelors degree in Biostatistics, Statistics, or a related field. Multi-year experience in: Clinical trial statistical design (including FDA NDA/BLA submission) and reporting Analytical validation for FDA registrational submissions in diagnostics, biotechnology, or related industries. Practical experience with statistical analysis software such as R, SAS, JMP, etc. Prior experience with cell therapy / CAR‑T a plus Knowledge, Skills, And Abilities Demonstrated ability and enthusiasm for working on cross‑functional teams with members of diverse technical backgrounds Strong track record of producing high quality written documentation for multiple audiences Exceptional problem‑solving skills and attention to detail #J-18808-Ljbffr Nexcella, Inc.