Principal Statistical Programmer (SDTM) in India at 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.

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.
• Mentoring and supporting programming team members through training, feedback, knowledge sharing, and review of technical work.
• Following applicable SOPs, work instructions, ICH guidelines, and regulatory standards throughout all activities.

The ideal candidate brings extensive statistical programming experience within clinical research environments, strong technical expertise, and the ability to lead complex projects. Required qualifications and skills include:

• Bachelor’s degree, preferably in a scientific, statistical, computer science, or related discipline, or equivalent combination of education and professional programming experience.
• Extensive experience using SAS or similar programming tools, preferably within clinical trial environments.
• Strong knowledge of SDTM standards and clinical data programming processes.
• Experience generating clinical trial datasets, tables, listings, and graphical outputs according to regulatory and sponsor requirements.
• Ability to review and interpret complex clinical documentation, including protocols, statistical analysis plans, and programming specifications.
• Strong understanding of quality control processes, validation programming, and regulatory compliance requirements.
• Excellent analytical, problem-solving, and organizational skills.
• Ability to manage priorities across multiple projects while meeting strict deadlines.
• Experience providing technical guidance, mentoring, and support to other programmers.
• Excellent written and verbal communication skills.
• Ability to communicate effectively in English with global teams and stakeholders.

The role offers the opportunity to contribute to global clinical research while working in a supportive and growth-focused environment. Benefits include:

• Remote work opportunity based in India.
• Full-time employment within a global healthcare and clinical research environment.
• Opportunity to work on innovative clinical development projects that impact patient care.
• Collaboration with international teams and experienced industry professionals.
• Career development opportunities through training, mentorship, and technical growth programs.
• Exposure to advanced clinical technologies, data standards, and research methodologies.
• Opportunity to develop leadership skills through project ownership and team mentoring.
• A mission-driven environment focused on accelerating healthcare solutions.