Principal Statistical Programmer – Remote (India)
Job Summary:
Syneos Health is hiring a highly experienced Principal Statistical Programmer to lead global programming initiatives in clinical trials. This remote position, based in India, is ideal for professionals with strong expertise in SAS, CDISC (SDTM & ADaM), and regulatory submissions. This is your opportunity to be part of a mission-driven, global pharmaceutical organization impacting the delivery of innovative therapies.
Key Responsibilities:
Develop SAS programs to generate TLFs, datasets, and graphs per SAP.
Perform validation programming and collaborate with biostatisticians and teams.
Lead programming activities across multiple complex clinical projects.
Develop and review specifications, SOPs, macros, and programming tools.
Conduct internal and sponsor meetings, and participate in bid defense and kick-off meetings.
Ensure compliance with ICH-GCP, CDISC, regulatory standards, and quality documentation.
Serve as a subject matter expert for CDISC standards and regulatory compliance (including Define.xml).
Mentor junior programmers and contribute to cross-functional collaboration.
Ensure timely delivery of programming deliverables with quality assurance.
Required Skills & Qualifications:
Bachelor’s degree in scientific/statistical discipline or equivalent experience.
Extensive programming experience in SAS within a clinical trial environment.
Proven experience leading multiple global programming projects.
Strong knowledge of CDISC standards including SDTM, ADaM, and regulatory submissions.
Experience with electronic submissions to regulatory agencies (FDA, EMA).
Excellent written and verbal English communication skills.
Demonstrated ability to manage multiple projects and mentor team members.
Perks & Benefits:
Remote work flexibility across India
Career advancement and training programs
Access to global clinical trial projects
Diverse and inclusive work culture
Recognition and rewards for performance
Total Self wellness and engagement initiatives
Company Description:
Syneos Health is a leading, fully integrated biopharmaceutical solutions organization supporting the delivery of novel therapies. Operating in over 110 countries, we specialize in clinical development, medical affairs, and commercialization, helping life sciences companies bring innovations to market faster and more efficiently.
Work Mode: Remote (India)
Call-to-Action:
Are you ready to drive statistical programming excellence in global clinical research? Apply now to join Syneos Health as a Principal Statistical Programmer and be part of an organization that is transforming lives through science.
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