Position Summary

The Associate Director, Statistical Programmer will lead statistical programming activities in support of Immix Biopharma’s clinical development programs. This role requires strong technical expertise in SAS programming, deep knowledge of CDISC standards, and the ability to deliver high-quality, regulatory-compliant outputs in a fast-paced, small-biotech environment.

Key Responsibilities

• Lead statistical programming activities for assigned clinical studies across the full study lifecycle with full accountability for the quality and integrity of all programming deliverables.
• Serve as the production programmer for SDTM and ADaM specifications, all SDTM and ADaM datasets, and all TFL outputs.
• Develop SDTM and ADaM specifications in accordance with CDISC standards.
• Supervise the independent validation of all SDTM datasets, ADaM datasets, and TFL outputs performed by an independent programmer.
• Generate the Data Package for Module 5 of BLA submissions. Key documents typically include:
• SDTM datasets
• ADaM datasets
• Define.xml (SDTM and ADaM)
• Study Data Reviewer’s Guide (SDRG)
• Analysis Data Reviewer’s Guide (ADRG)
• Annotated Case Report Forms (aCRF)
• TFL outputs
• Integrated datasets supporting ISS and ISE (if applicable)
• Work closely with the Lead Biostatistician to document all completed work through a formal Cover Page confirming accountability and that the work was performed correctly.
• Provide hands-on SAS programming support for key analyses, data exploration, ad-hoc requests, and regulatory deliverables.
• Support BLA submissions, including preparation and quality control of integrated datasets, TFLs, and related submission components.
• Ensure submission readiness of study data packages in accordance with CDISC standards and FDA guidance.
• Collaborate with Biostatistics, Clinical Data Management, Clinical Operations, Pharmacovigilance, and other cross-functional teams.
• Review protocols, SAPs, CRFs, and data management documents from a programming perspective.
• Contribute to the continuous improvement of statistical programming processes, standards, and infrastructure.

Qualifications

• Master’s degree (or higher) in a related quantitative or research field (e.g., Research, Biostatistics, or Mathematics) and a Bachelor’s degree in Computer Science.
• Minimum of 8–10 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry.
• Strong proficiency in SAS (Base SAS, SAS/STAT, SAS Macro, ODS) with demonstrated ability to develop complex, validated programs. SAS Programming Certificate preferred.
• Extensive experience with CDISC standards (SDTM, ADaM), Define.xml, and electronic submission requirements.
• Solid understanding of clinical trial processes, regulatory requirements (FDA, ICH), and GCP.
• Experience supporting regulatory submissions (e.g., NDA/BLA) preferred.
• Additional training or certification in data science or related quantitative methods is a plus.
• 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.

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.