R&D Programmer III

Job Title : R&D Programmer III

Job Location : Fully Remote (Poland-based candidates only)

Schedule : Sunday Thursday, 8 : 00 AM 5 : 00 PM (Poland time zone)

Position Summary

We are seeking an experienced Statistical Programming Contractor (Level 3) to provide advanced SAS programming support for clinical trials. This role involves the independent management of programming deliverables at the study and program level, ensuring compliance with global regulatory requirements (CDISC, ICH) while supporting drug development across multiple therapeutic areas.

The ideal candidate will possess expert SAS programming skills, strong statistical knowledge, and proven experience in delivering analysis datasets, TLGs, and CDISC-compliant e-submissions.

Key Responsibilities

Provide comprehensive programming support at the study, product, and program levels .

Develop, debug, and enhance SAS programs to support quality control of safety and efficacy datasets, TLGs, and CDISC-based e-submissions.

Create ADaM specifications, analysis datasets, and mock TLGs, ensuring compliance with regulatory requirements and departmental SOPs.

Implement programming standards and proactively communicate issues impacting deliverables.

Contribute to process improvement and standardization of deliverables across therapeutic areas.

Provide input to study design, statistical analysis, and publication support for marketed drugs.

Collaborate with cross-functional teams (Statistics, Data Management, Regulatory) to ensure quality deliverables.

Education :

Bachelor s degree + 7 years experience OR Master s degree + 6 years experience in Statistics, IT, or related scientific field.

Experience Required :

Extensive programming experience in pharmaceutical / clinical research environments.

Expert knowledge of SAS and problem resolution skills.

Strong understanding of clinical trials, drug development, and statistical concepts .

Proficiency in SDTM, ADaM standards, Pinnacle 21, XML, and MS Office .

Ability to work independently and collaboratively in global teams.

Experience Preferred :

Solid knowledge of statistical models used for efficacy analysis.

Advanced knowledge of government regulations (CDISC, ICH guidelines) across therapeutic areas.

Experience creating ISS / Client datasets and BIMO Inspection deliverables .

Core Competencies

Tackles complex problems, identifies solutions, and drives decisions.

Strong written and verbal communication skills.

Ability to influence team communication toward common understanding and actionable outcomes.

Proactive, detail-oriented, and quality-focused.