Principal Statistical Programmer(ADAM & TLF)

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Statistical Programmer (ADAM & TLF) in India.

This role offers the opportunity to lead high-impact statistical programming activities within clinical development, contributing directly to the generation of reliable evidence that supports regulatory submissions and patient outcomes. You will work in a highly collaborative global environment, partnering with statisticians, clinical teams, and stakeholders to design, validate, and deliver high-quality analysis datasets and statistical outputs. The position combines deep technical expertise in clinical programming with leadership responsibilities, including mentoring junior programmers and shaping best practices. You will play a key role in ensuring data integrity, compliance, and efficiency across complex clinical studies. This is a highly visible role where your work will directly support decision-making in drug development programs. The environment is dynamic, science-driven, and focused on continuous improvement and innovation in clinical analytics.

You will provide technical leadership in statistical programming activities across clinical studies, ensuring high-quality deliverables and compliance with industry standards. You will collaborate closely with cross-functional teams to translate statistical requirements into robust programming solutions that support clinical research and regulatory submissions.

• Lead the development and maintenance of statistical programming standards and best practices across clinical projects
• Design, develop, and validate ADaM datasets and TLF outputs using SAS programming in clinical environments
• Collaborate with statisticians and clinical stakeholders to understand analysis requirements and translate them into programming specifications
• Ensure accuracy, consistency, and integrity of clinical data and statistical outputs across studies
• Perform complex troubleshooting and resolve programming issues in clinical datasets and analysis workflows
• Conduct code reviews and provide mentorship to junior programmers to ensure high-quality deliverables
• Contribute to process improvement initiatives and optimization of programming tools and workflows
• Support study-level leadership, including coordination of programming activities and client interaction where required

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Requirements

The ideal candidate brings strong clinical statistical programming expertise, leadership experience, and deep knowledge of ADaM and TLF development within regulated environments.

• 8+ years of experience in clinical statistical programming using SAS (Base and Advanced SAS)
• Strong expertise in ADaM standards, dataset creation, and TLF programming for clinical trials
• Experience working on integrated datasets, including ISS/ISE and pooled study analyses (preferred)
• Proven ability to lead studies and interact with clients or cross-functional stakeholders
• Solid understanding of safety and efficacy data analysis in clinical research environments
• Strong proficiency in statistical programming languages and data analysis methodologies
• Familiarity with regulatory standards and clinical data requirements
• Strong analytical, problem-solving, and troubleshooting skills
• Excellent communication skills with ability to work in global, cross-functional teams
• Ability to mentor and guide junior programmers and ensure quality standards

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Benefits

• Competitive compensation aligned with experience and industry standards
• Opportunity to work on global clinical trials impacting drug development and patient outcomes
• Career development and progression within a leading life sciences environment
• Collaborative global teams with strong technical and scientific expertise
• Exposure to large-scale, complex clinical datasets and regulatory-grade submissions
• Learning opportunities in advanced statistical programming and clinical analytics
• Inclusive and supportive work culture focused on continuous improvement and innovation