DST is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Statistical Programmer on a permanent basis.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

The Statistical Programmer I is responsible for executing programming tasks related to the annotation of Case Report Forms (CRFs) and the development of statistical datasets in compliance with FDA and CDISC guidelines. This role involves generating SDTM and ADaM datasets, creating tables, listings, and figures for clinical study reports, and preparing electronic submission packages for regulatory agencies. The Statistical Programmer I collaborates closely with statisticians to analyze data and interpret results, actively contributing to innovative programming solutions. Additionally, this position serves as a team lead, providing guidance and mentoring to junior team members while ensuring the quality and consistency of project deliverables.

Main Job Tasks and Responsibilities:

• Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor
• Develop SDTM specifications and generate SDTM datasets using SAS.
• Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
• Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical
• Study Report, Posters, Manuscripts.
• Develop ADaM data, Tables, Listings, Figures for Integrated Summary of
• Safety (ISS) and Integrated Summary of Efficacy (ISE).
• Create electronic submission package to FDA, e.g., define.xml or pdf following FDA guidelines with minimum supervision.
• Analyze information and develop innovative solutions to programming and data analysis challenges.
• Actively communicate with statisticians for statistical input and analysis
• Follow and reinforce regulatory agency requirements during daily job.
• Serve as a programming team lead and contribute to department initiative.
• Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
• Review draft and final production deliverables for project to ensure quality and consistency.

Education and Experience:

• Bachelor’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines.
• Minimum of 0 to 3 years of relevant clinical programming experience.
• Proven knowledge and training in high level computing languages such as SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus.
• Proficient in decoding programming logic and assembling, programming code based on logic provided and be able to explain to team members.
• Proficient in applying concepts in Artificial Intelligence and Machine
• Learning in the real world.
• In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Good understanding of clinical drug development process.
• Strong communication skills and coordination skills. ability to communicate with global teams with supervision.
• In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• Good understanding of clinical drug development process.
• Detail-oriented and ability to learn and adapt to changes.

Our Benefits:

• Flexible Working Hours
• Full performance and development process with end of year reviews
• Employee satisfaction survey — your feedback is important for continuous improvement
• Health Insurance