Clinical SAS Programmer

Responsibilities

• Effectively design and code SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects.
• Produce and deliver CDISC and regulatory-compliant SDTM and ADaM standard datasets.
• Create and validate tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting study objectives and regulatory requirements.
• Provide input in the design and development of case report forms and clinical databases.
• Perform quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM, ADaM datasets and TFLs.
• Program quality checks for clinical study raw data and report findings to Data Management.
• Provide programming support for ad‑hoc analysis.
• Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications).
• Manage timelines and schedules of specific phases of projects with internal personnel and external vendors.
• Act as lead programmer for a study.
• Review or validate statistical deliverables of vendors for assigned projects.

• MS in Statistics, Computer Science, or a related field with at least 3 years of experience, or BS in the same field with at least 5 years of 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.
• Good written and verbal communication skills and strong 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 multi‑task effectively.
• Demonstrated positive attitude and ability to work well with others.

Associate

Contract

Information Technology

Pharmaceutical Manufacturing

Location: Omaha, NE

Compensation: $85,000.00–$ annually