Senior Statistical Programmer, SDTM

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

📋 Description

• Offer technical expertise in supporting the analysis and reporting activities of clinical trials.

• Assist in the provision of high-quality statistical programming solutions.

• Serve as a Statistical Programming Coordinator on projects when necessary.

• Collaborate with sponsors, Data Operations Leads, biostatisticians, and various cross-functional teams.

• Program derived datasets for clinical studies.

• Execute quality control programming tasks.

• Create mapping specifications.

• Carry out import and export programming functions.

• Comply with industry data standards and regulatory requirements.

• Manage study and project initiation activities.

• Diagnose and debug SAS macros.

• Develop SDTM Trial Design domains and intricate SDTM datasets.

• Evaluate Protocols and Statistical Analysis Plans, offering insights on SDTM mapping strategies.

• Participate in initiatives for process improvements.

• Provide technical leadership and offer support for technical training, mentoring, or guidance.

⛳️ Requirements

• Bachelor’s degree in a relevant field or equivalent professional experience.

• Experience in the clinical trial industry.

• Proficient in SAS programming.

• Strong understanding of programming and reporting processes.

• Familiarity with ICH-GCP standards.

• Knowledge of regulatory requirements.

• Understanding of System Life Cycle methodologies.

• Awareness of industry technical standards, including 21 CFR Part 11.

• Background in supporting statistical programming tasks related to clinical study analysis and reporting.

• Excellent written and verbal communication skills in English.

• Strong organizational abilities.

• Capability to manage competing priorities effectively.

• Adaptability in a fast-paced environment.

• Dedication to quality management, teamwork, and problem-solving.

• Proven experience as an SDTM Lead in clinical research studies.

• Experience in developing SDTM Trial Design domains.

• Ability to program and produce complex SDTM datasets.

• Experience in coordinating study and project initiation activities.

• Proficiency in troubleshooting and debugging moderately complex macros.

• Understanding of efficacy endpoints and assessment methodologies, including RECIST and IMWG.

• Experience in reviewing Protocols and Statistical Analysis Plans (SAPs).

• Familiarity with CDISC standards, development of mapping specifications, and regulatory submission requirements.

• Over 5 years of experience as a Statistical Programming Coordinator or study lead on clinical research projects (preferred).

• Experience in developing standard macros, applications, or programming solutions to enhance efficiency (preferred).

• Background in providing technical training, mentoring, or guidance (preferred).

🏝️ Benefits

• Remote work options available.

• Opportunity to collaborate with global teams.

• Continuous learning opportunities.

• Chances to develop technical, leadership, and project delivery skills.

• Engagement in challenging projects.

• Opportunities for process improvement and technical leadership.