Clinical SAS Programmer

Responsibilities

• Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects.
• Produces and delivers CDISC‑ and regulatory‑compliant SDTM and ADaM standard datasets.
• Creates and validates tables, figures, and listings (TFLs) in a timely, high‑quality fashion, consistently meeting study objectives and regulatory requirements.
• Provides input in the design and development of case report forms and clinical databases.
• Performs quality‑control checks and validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets, and TFLs.
• Programs quality checks for clinical study raw data and reports findings to Data Management.
• Reviews or authors eCRF, SDTM, and ADaM dataset specifications for programming.
• Provides programming support for ad‑hoc analysis.
• Identifies problems and develops global tools (e.g., macros or graphical user‑interface applications) that increase the efficiency and capacity of the Statistical Programming group.
• Manages timelines and schedules of specific project phases with internal personnel and external vendors.
• Acts as lead programmer for a study.
• Reviews or validates statistical deliverables of vendors for assigned projects.

Requirements

• MS in Statistics, Computer Science, or a related field with at least 3 years experience, or BS in Statistics, Computer Science, or a related field with at least 5 years experience.
• Experience providing statistical programming support to early‑ and late‑phase clinical trials.
• Excellent skills in SAS programming and statistical reporting.
• Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
• Familiarity with FDA and ICH regulations and guidelines.
• Excellent problem‑solving skills.
• Strong written and verbal communication, organizational, and documentation skills.
• Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
• Ability to prioritize and multitask effectively.
• Demonstrated positive attitude and ability to work well with others.