Principal Stat Programmer(SDTM, ADaM, TLF)

About This Opportunity

We are representing a confidential life sciences organization seeking a Principal Statistical Programmer to join their Clinical Solutions team in India. This is a senior technical leadership role where you'll develop programming code for clinical trial deliverables, mentor team members, and serve as a technical expert for industry standards including CDISC, SDTM, and ADaM.

Responsibilities

• Develop custom programming code using SAS or other software to generate summary tables, data listings, graphs, and derived datasets according to statistical analysis plans and programming specifications
• Perform validation programming and collaborate with programmers, biostatisticians, and project teams to resolve discrepancies and findings
• Lead statistical programming activities, directing other programming personnel and monitoring progress on deliverables across concurrent projects
• Develop specifications for datasets and outputs of any complexity according to statistical or sponsor requirements
• Review project documentation including Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and database designs
• Participate in sponsor meetings, kickoff meetings, and bid defense meetings as the statistical programming representative
• Serve as technical subject matter expert for CDISC and regulatory requirements, providing guidance and training to biostatistics teams
• Perform compliance reviews of CDISC deliverables including SDTM and ADaM specifications and datasets, as well as regulatory documents such as DEFINE.XML
• Contribute to mentoring programming personnel through developing training courses, presenting materials, and providing technical feedback
• Develop programming tools and macros for standardization and efficiency
• Maintain complete project documentation, testing, and quality control documents ensuring inspection readiness
• Follow applicable SOPs, work instructions, and relevant regulatory guidelines (e.g., ICH)

What We're Looking For

• Advanced degree in Statistics, Computer Science, or a related field
• Proven experience in statistical programming and data analysis within clinical trials
• Strong knowledge of programming languages such as SAS, R, or Python
• Deep expertise with CDISC standards including SDTM, ADaM, and TLF (Tables, Listings, Figures)
• Proficiency in statistical programming and data manipulation
• Strong understanding of statistical methodologies and data analysis techniques
• Familiarity with data visualization tools and techniques
• Experience leading programming teams and managing deliverables across multiple concurrent projects
• Excellent problem-solving and analytical skills with attention to detail
• Strong communication and collaboration skills
• Ability to work independently and adapt to changing project requirements
• SAS Certified Advanced Programmer for SAS 9 or equivalent certification preferred
• Certification in data analysis or statistical programming is a plus

How We Work With You

Candidates apply through Get A Job.ai. Our talent team will screen your application and qualifications. If there's a strong match, we'll submit your profile to our client for consideration. Please do not contact the client directly—all communication flows through our recruiting team to ensure a professional, coordinated process.

Pay

Compensation details will be discussed during the screening process based on your experience and qualifications.

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