Principal Statistical Programmer SDTM - jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal Statistical Programmer (SDTM) based in India.

We are seeking a Principal Statistical Programmer specializing in SDTM to support the development and delivery of high-quality clinical trial programming solutions. The role involves transforming clinical data into accurate statistical outputs that support regulatory submissions and healthcare advancements. You will lead complex programming activities, collaborate with cross-functional clinical teams, and ensure compliance with industry standards. This position offers the opportunity to apply advanced SAS programming expertise while contributing to impactful clinical research projects. You will provide technical leadership, mentor programming teams, and help optimize processes across multiple studies. The ideal candidate is an experienced statistical programmer with strong analytical skills, attention to quality, and a passion for improving patient outcomes through data-driven research.

Accountabilities:

The Principal Statistical Programmer (SDTM) will lead statistical programming activities, ensuring the delivery of accurate, compliant, and high-quality clinical trial outputs. Key responsibilities include:

• Developing statistical programming code using SAS or other relevant software to generate summary tables, listings, graphs, and derived datasets according to statistical analysis plans and programming specifications.
• Performing validation programming, reviewing outputs, and collaborating with programmers, biostatisticians, and project teams to resolve discrepancies and quality findings.
• Ensuring programming deliverables meet quality standards, regulatory requirements, and project timelines.
• Maintaining complete and inspection-ready project documentation, including testing, verification, quality control records, and programming documentation.
• Developing specifications for datasets and outputs of varying complexity while ensuring alignment with statistical and sponsor requirements.
• Managing multiple projects simultaneously, prioritizing workload, adapting to changing timelines, and delivering programming activities within agreed deadlines.
• Identifying potential programming challenges proactively and implementing efficient solutions to minimize rework.
• Acting as a lead statistical programmer by coordinating programming activities, monitoring deliverables, and supporting team members.
• Reviewing key study documentation, including statistical analysis plans, mock shells, programming specifications, annotated CRFs, and database designs.
• Participating in sponsor meetings, project kickoffs, and related discussions as a statistical programming representative when required.