VP Data Science – FDA BLA Submission (Clinical Trial Statistical Design)

VP Data Science – FDA BLA Submission (Clinical Trial Statistical Design)

Los Angeles / Hybrid

Our 3 Core Values

• Intelligence

• Integrity

• Initiative

Our mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessible cures. Patients are waiting!

What You Will Do

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

About Nexcella, Inc.

Nexcella, Inc. is a subsidiary of Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a “digital filter” that filters out non-specific activation. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a registrational design. Interim results were presented at ASCO 2025 in an oral presentation. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at www.nexcella.com and www.BeProactiveInAL.com.