Nexcella, Inc. · 1 day ago
Lead Biostatistician – FDA BLA Submission (Clinical Trial Statistical Design)
Greater Los Angeles, CA
Full-time
Hybrid
Lead/StaffNexcella, Inc. is a subsidiary of Immix Biopharma, Inc. focused on developing innovative cell therapies. They are seeking a Lead Biostatistician to lead global Biostatistics efforts, including drafting statistical analysis plans and working on FDA BLA submissions.
BiotechnologyHealth Care
Responsibilities
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
Qualification
Required
Ph.D., Master's, or bachelor's 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
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
Preferred
Prior experience with cell therapy / CAR-T a plus
Company
Nexcella, Inc.
2-10 employees
Funding
Current Stage
Early StageTotal Funding
$8MKey Investors
California Institute for Regenerative Medicine
2024-07-25Grant· $8M
Leadership Team
David Stephens
CFO
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