Position Title:

Analyst, Statistical Programming Work Location:

Irvine CA Assignment Duration:

6

Months Work Arrangement:

Hybrid (high preference for onsite; open to remote)

Position Summary:

The main function of an analyst is to support clinical research activities by developing, validating, and maintaining clinical study datasets, tables, figures, and listings. This role works closely with Biostatistics, Clinical Data Management, and cross-functional study teams to support regulatory submissions, scientific publications, routine reporting, and clinical study analyses.

Key Responsibilities:

Develop and validate SDTM and ADaM datasets from clinical study data. Create, maintain, and validate SAS and/or R programs for data processing and statistical reporting. Generate and quality check Tables, Figures, and Listings (TFLs) for clinical study reports, regulatory submissions, publications, and presentations. Support data review, analysis data readiness, routine reports, safety reporting, and ad hoc analyses. Participate in the implementation of Statistical Analysis Plans (SAPs) and programming specifications. Ensure compliance with company standards, quality procedures, and regulatory requirements. Collaborate with Biostatistics, Clinical Data Management, Clinical Development, Clinical Safety, and Medical Affairs teams to support study deliverables. Contribute to programming standards, automation, utility macros, and process improvement initiatives.

Qualification & Experience:

Bachelor's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a related field. 2-4 years of experience with SAS programming; knowledge of R is preferred. Understanding of clinical trial data, statistical reporting, and regulatory requirements. Knowledge of CDISC SDTM and ADaM standards preferred. Strong analytical, problem-solving, and communication skills. Ability to manage multiple priorities and work effectively in a collaborative team environment.