Principal Statistical Programmer (SDTM)

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.

Requirements:

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.

Benefits:

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.