Position Summary

The Associate Director, Biostatistics will provide statistical leadership and scientific expertise in support of Immix Biopharma’s clinical development programs. This role is responsible for ensuring high-quality statistical design, analysis, and interpretation of clinical trial data to support regulatory submissions and publications. The position requires strong technical expertise in biostatistics, deep knowledge of regulatory requirements, and the ability to work effectively in a fast-paced, small-biotech environment.

Key Responsibilities

·      Provide statistical leadership for assigned clinical studies across the full study lifecycle with full accountability for the quality and integrity of all statistical deliverables.

·      Lead the development of statistical sections of clinical protocols, Statistical Analysis Plans (SAPs), and related study documents.

·      Perform sample size calculations, power analyses, and meta-analyses to support study design and regulatory submissions.

·      Oversee statistical analyses and interpretation of clinical trial results.

·      Perform statistical QC from raw data to ADaM datasets for all endpoints (efficacy, safety, immunogenicity, and exploratory) and all key variables.

·      Conduct statistical QC of all TFLs, with special attention to those presenting endpoint results.

·      Generate TFL shells with clear specifications and SAS code examples for complex statistical analyses.

·      Generate internal timelines for deliverables, including Dry Runs, final analysis, and ad-hoc analysis.

·      Collaborate with the Statistical Programming team to ensure accurate production and validation of SDTM datasets, ADaM datasets, and TFL outputs.

·      Contribute statistical input to the Module 5 Data Package for BLA submissions, including integrated analyses.

·      Support BLA and other regulatory submissions by providing statistical expertise for integrated summaries and responses to health authorities.

·      Partner with Clinical Development, Clinical Operations, Data Management, Pharmacovigilance, Regulatory, and Medical Affairs to align on study design, analysis, and reporting.

·      Provide statistical input on clinical study reports, publications, and other scientific documents.

·      Contribute to the continuous improvement of biostatistics processes, standards, and infrastructure.

Qualifications

·      PhD in Biostatistics or Statistics with a minimum of 8 years of experience as a biostatistician, or Master’s degree in Biostatistics, Statistics with a minimum of 15 years of experience as a biostatistician.

·      Strong knowledge of statistical methods used in clinical trials, including study design, sample size estimation, and analysis of clinical endpoints.

·      Extensive experience with regulatory requirements (FDA, ICH) and submission processes (e.g., NDA/BLA).

·      Solid understanding of CDISC standards (SDTM, ADaM) and their application in clinical trial analysis and reporting.

·      Experience supporting regulatory submissions and interacting with regulatory agencies preferred.

·      Strong attention to detail, organizational skills, and ability to manage multiple priorities in a dynamic environment.

·      Excellent written and verbal communication skills, with the ability to work collaboratively in cross-functional teams and clearly explain statistical concepts to non-statisticians.

 About Immix Biopharma

Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company developing cell therapies for AL amyloidosis and other serious diseases. The company’s lead candidate, NXC-201, is a BCMA-targeted CAR-T cell therapy being evaluated in clinical studies for relapsed/refractory AL amyloidosis.

Equal Opportunity Statement

Immix Biopharma is an equal opportunity employer. The company is committed to building a diverse and inclusive workplace and considers qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, age, or any other status protected by applicable law.