Location: India (Remote)
Company: Syneos Health
Job ID: 25107315
Experience Required: 8+ years (Not suitable for freshers)
About the Company
Syneos Health is a leading global biopharmaceutical solutions organization that supports the full drug development lifecycle. With a strong presence across clinical development, data sciences, and commercialization, the company collaborates with innovators worldwide to accelerate patient access to life-saving therapies.
Job Overview
The Senior / Principal Statistical Programmer is a high-impact role responsible for leading advanced statistical programming activities within clinical trials. This position requires deep expertise in SAS programming, CDISC standards, and regulatory submissions, along with the ability to manage multiple complex projects in a global CRO environment.
This role is ideal for experienced professionals who can independently lead programming deliverables, mentor teams, and ensure compliance with global regulatory standards.
Key Responsibilities
Develop and validate SAS programs to generate Tables, Listings, and Figures (TLFs) as per Statistical Analysis Plans
Create and manage analysis datasets including SDTM and ADaM in compliance with CDISC standards
Perform validation programming and resolve discrepancies in collaboration with biostatisticians and cross-functional teams
Lead statistical programming activities and oversee deliverables across multiple concurrent studies
Review key study documents including SAPs, annotated CRFs, and programming specifications to ensure accuracy and efficiency
Support regulatory submissions by preparing submission packages including define.xml and ADRG
Act as subject matter expert for CDISC standards, ensuring compliance across all deliverables
Participate in sponsor meetings, bid defenses, and project kickoff discussions as programming lead
Mentor junior programmers, conduct training sessions, and contribute to capability building within the team
Develop and standardize programming macros and tools to improve efficiency and quality
Ensure all deliverables meet ICH guidelines, SOPs, and regulatory requirements
Maintain audit-ready documentation and ensure inspection readiness
Required Qualifications
Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field
Minimum 8+ years of Clinical SAS Programming experience in a CRO or pharmaceutical environment
Strong hands-on experience in ADaM, SDTM, and TLF programming (safety and efficacy outputs)
Proven experience in regulatory submission packages including define.xml and ADRG
In-depth understanding of CDISC standards and global regulatory requirements
Excellent communication, problem-solving, and leadership skills
Ability to manage multiple projects and deliver within tight timelines
Preferred Skills
Experience as a lead statistical programmer in global clinical trials
Exposure to regulatory submissions (FDA, EMA)
Strong knowledge of clinical trial data structures and reporting standards
Why This Role Matters
Direct involvement in global clinical trials and regulatory submissions
Opportunity to work as a technical leader in a high-growth CRO environment
Exposure to cutting-edge drug development programs across therapeutic areas
Strong career advancement into leadership and principal-level roles
Important Note for Applicants
This is a senior-level position requiring extensive experience in statistical programming and clinical trials. Freshers or early-career professionals are advised to begin with entry-level roles such as Statistical Programmer I or Clinical Data Analyst before progressing to this level.
How to Apply
Apply through the official careers page of Syneos Health or explore more verified global opportunities on ThePharmaDaily.com, your trusted platform for clinical research, pharmacovigilance, and biostatistics careers.
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