Statistical Programmer II – SDTM

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

📋 Description

• Evaluate and provide insights on Protocol and SAP concerning SDTM mappings

• Design SDTM trial domains

• Program intricate SDTM datasets

• Troubleshoot basic to intermediate macros

• Assist the SDTM Lead

• Help coordinate project initiation activities

• Prepare submission documentation

• Act as a primary statistical programming liaison on assigned projects

• Collaborate with sponsors, Data Operations Leads, and multidisciplinary teams

• Create and assess SDTM mappings, trial design domains, and advanced SDTM datasets

• Implement effective programming methodologies

• Promote process enhancements through macro and application development

• Contribute to regulatory submissions and pivotal study decisions

⛳️ Requirements

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, Pharmacy, or a related field, or equivalent experience

• Over 3 years of experience in SDTM statistical programming

• Proficient in SAS with knowledge of programming and reporting protocols

• Familiarity with regulatory standards and industry technical guidelines related to clinical trial data

• Experience in developing SDTM trial design domains and complex SDTM datasets

• Exceptional written and verbal communication skills, with proficiency in written English

• Strong organizational, teamwork, and project management abilities

• Capability to adjust to evolving priorities while managing complex project outcomes

• Understanding of efficacy endpoints and related concepts (e.g., RECIST application, IMWG)

• Strong competencies in SAS programming, SDTM dataset creation, and problem-solving

• Experience in clinical research or another regulated setting

• Skills in simple to moderate macro debugging

• Solid foundational skills in SAS

🏝️ Benefits

• Opportunities for continuous learning

• Potential for career advancement

• Diverse team environment

• Ability to work remotely