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

Lead Biostatistician – FDA BLA Submission (Clinical Trial Statistical Design)Immix Biopharma, Inc.Los Angeles, CA / HybridOur 3 Core Values IntelligenceIntegrityInitiativeOur 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 DoThis is an exciting opportunity to lead our global Biostatistics efforts.Clinical Trial Statistical Design and BLA SubmissionDraft accurate, clear and detailed statistical analysis plans (SAPs) and related clinical protocolsWork with team /program ADaM and SDTM outputs for FDA BLACommunicate, 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 neededWhat We Look ForBachelor’s dPh.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 reportingAnalytical 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 plusKnowledge, Skills, And AbilitiesDemonstrated ability and enthusiasm for working on cross-functional teams with members of diverse technical backgroundsStrong track record of producing high quality written documentation for multiple audiencesExceptional problem-solving skills and attention to detailAbout Immix BiopharmaImmix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is the global leader in relapsed/refractory AL Amyloidosis. AL Amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a “digital filter” that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a registrational design. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA.