Senior Statistical Programmer, FSP

This is a fully remote position, open to applicants in India, +2 more countries.

📋 Description

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

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

• Execute production and quality control/validation programming.

• Generate complex ad-hoc reports utilizing raw data.

• Leverage a strong understanding and experience in efficacy analysis.

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

• Liaise with internal cross-functional teams and clients regarding project specifications, progress, challenges, and inquiries.

• Undertake lead responsibilities when necessary.

• Collaborate effectively as a team member to achieve objectives and meet deadlines.

• Adjust to shifting priorities as required.

⛳️ Requirements

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

• A minimum of 6 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech industry, possessing a bachelor’s degree or equivalent.

• At least 4 years of relevant experience with a master’s degree or higher.

• Preferred experience as a study lead.

• Strong skills in SAS data manipulation, analysis, and reporting.

• Extensive experience in implementing the latest CDISC SDTM / ADaM standards.

• Proficient QC / validation skills.

• Competent ad-hoc reporting capabilities.

• Expertise in efficacy analysis.

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

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

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

• Outstanding analytical and troubleshooting abilities.

• Capacity to deliver quality outputs and deliverables within stringent timelines.

• Ability to collaborate effectively in a globally distributed team environment with cross-cultural partners.

🏝️ Benefits

• Ongoing training, development, and support.

• Significant opportunities for professional growth.