Senior Statistical Programmer, FSP

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

📋 Description

• Serve as a sponsor-dedicated Senior Statistical Programmer, fully integrated with a pharmaceutical client.

• Assist or take the lead on multiple Phase I-IV clinical trials.

• Conduct data manipulation, analysis, and reporting of clinical trial data, focusing on safety and efficacy (ISS/ISE) using SAS.

• Produce and validate SDTM and ADaM datasets/analysis files, tables, listings, and figures (TLFs).

• Execute production and QC/validation programming tasks.

• Create complex ad-hoc reports utilizing raw data.

• Leverage expertise in efficacy analysis.

• Develop and review submission documents and electronic Case Report Tabs (eCRTs).

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

• Assume leadership responsibilities when required.

• Adjust to shifting priorities and assist in meeting delivery deadlines.

⛳️ Requirements

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

• A minimum of 5 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech sector.

• Preferred experience as a study lead.

• Exceptional SAS data manipulation, analysis, and reporting capabilities.

• Strong background in implementing CDISC SDTM / ADaM standards.

• Proficient in QC and validation processes.

• Competent in generating ad-hoc reports.

• Expertise in efficacy analysis.

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

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

• Background in supporting immunology, respiratory, or oncology studies is a plus.

• Excellent analytical and troubleshooting abilities.

• Capacity to deliver high-quality outputs and meet deliverables within tight timelines.

• Ability to collaborate effectively within a globally dispersed team environment with partners from diverse cultures.

🏝️ Benefits

• Ongoing training, development, and support.

• Significant opportunities for professional growth.