Senior Statistical Programmer, FSP

This is a fully remote position, open to applicants in Colombia.

📋 Description

• Conduct data manipulation, analysis, and reporting of clinical trial data, focusing on safety and efficacy, through SAS programming.

• Create and validate SDTM and ADaM datasets, as well as analysis files, tables, listings, and figures (TLFs).

• Execute production and QC/validation programming tasks.

• Develop intricate ad-hoc reports leveraging raw data.

• Utilize a robust understanding and experience in efficacy analysis.

• Draft and review submission documents and eCRTs.

• Liaise with internal cross-functional teams and clients about project specifications, status updates, issues, and inquiries.

• Collaborate as a team player to achieve outcomes and meet deadlines.

• Adjust to evolving priorities.

⛳️ Requirements

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related field.

• Minimum of 8 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech sector, holding a bachelor’s degree or equivalent.

• At least 6 years of relevant experience with a master’s degree or higher.

• Experience leading studies is preferred.

• Proficient in SAS data manipulation, analysis, and reporting.

• Comprehensive experience in implementing CDISC SDTM / ADaM standards.

• Strong skills in QC / validation processes.

• Competent in generating ad-hoc reports.

• Proficiency in efficacy analysis.

• Knowledge of the drug development life cycle and clinical trial data manipulation, analysis, and reporting.

• Experience with submissions using define.xml and other related documents.

• Background in supporting oncology or immunology studies is advantageous.

• Exceptional analytical and troubleshooting abilities.

• Capable of delivering high-quality output and deliverables under tight deadlines.

• Effective in collaborating within a globally distributed team environment with cross-cultural partners.

🏝️ Benefits

• Ongoing training, development, and support.

• Significant opportunities for professional growth.

• Fully remote work arrangement.