Principal Statistical Programmer

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

📋 Description

• Conduct data manipulation, analysis, and reporting of clinical trial data, encompassing safety and efficacy (ISS/ISE), utilizing SAS programming.

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

• Engage in production and quality control/validation programming.

• Create intricate ad-hoc reports using raw data.

• Leverage strong knowledge and experience in efficacy analysis.

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

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

• Assume lead responsibilities when required.

• Meet deadlines and collaborate effectively as a team member.

• Adjust to shifting priorities.

⛳️ Requirements

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

• Minimum of 6 years of SAS programming experience with clinical trial data in the Pharmaceutical & Biotech sector, holding a bachelor’s degree or equivalent.

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

• Experience as a study lead is preferred.

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

• Strong background in implementing CDISC SDTM / ADaM standards.

• Excellent quality control and validation skills.

• Good ability to generate ad-hoc reports.

• Expertise in efficacy analysis.

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

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

• Exceptional analytical and troubleshooting abilities.

• Capacity to deliver quality output and deliverables under tight timelines.

• Ability to work efficiently in a globally distributed team environment with cross-cultural collaborators.

🏝️ Benefits

• Ongoing training, development, and support.

• Considerable opportunities for professional growth.

• Fully remote work arrangement.