Principal Statistical Programmer (ADaM, TLF & SDTM)
Company: Syneos Health
Location: IND – Remote
Job ID: 25107309
Updated On: May 13, 2026
Experience Level: 8+ years
Company Overview
Syneos Health is a global life sciences services organization that supports drug development and commercialization. The company works across clinical trials, regulatory submissions, and statistical programming to accelerate healthcare innovation and bring therapies to market.
Role Summary
The Principal Statistical Programmer is a senior-level technical and leadership role responsible for:
Developing and validating clinical trial datasets and statistical outputs
Leading programming efforts across SDTM, ADaM, and TLF deliverables
Ensuring compliance with regulatory standards and CDISC requirements
Acting as a technical expert in SAS programming and clinical data standards
Key Responsibilities
1. Statistical Programming & Output Generation
Use SAS / other tools to develop:
Tables
Listings
Figures (TLFs)
Analysis datasets
Build outputs aligned with Statistical Analysis Plans (SAPs) and specifications
2. Dataset Development (SDTM & ADaM)
Develop and validate:
SDTM datasets
ADaM datasets
Create programming specifications for complex datasets
Ensure compliance with CDISC standards
3. Validation & Quality Control
Perform validation programming
Resolve discrepancies with biostatisticians and team members
Ensure outputs meet quality, regulatory, and sponsor standards
Maintain inspection-ready documentation
4. Leadership & Team Coordination
Act as Lead Statistical Programmer
Direct programming activities of junior programmers
Monitor deliverables and project progress
Participate in sponsor and kickoff meetings
5. Study Documentation Review
Review:
SAPs
Mock shells
Annotated CRFs
SAS database design
Provide feedback to improve efficiency and reduce rework
6. Compliance & Regulatory Standards
Follow SOPs, WIs, and regulatory guidelines (e.g., ICH)
Ensure CDISC compliance (SDTM, ADaM, DEFINE.XML)
Support regulatory submission readiness
7. Project Management & Delivery
Manage multiple concurrent projects
Ensure on-time delivery of programming outputs
Provide risk mitigation and timeline negotiation
Communicate issues and progress to management
8. Technical Expertise & Innovation
Serve as subject matter expert in:
SAS programming
CDISC standards
Clinical data structures
Develop macros and programming tools for efficiency
Contribute to standardization initiatives
9. Mentoring & Training
Mentor junior programmers
Conduct training sessions and technical guidance
Review work and provide feedback for skill development
Required Skills & Expertise
Technical Skills
8+ years in Clinical SAS Programming
Strong expertise in:
Base SAS
SAS Macros
SDTM & ADaM programming
TLF generation
Experience with Safety & Efficacy outputs
Oncology therapeutic area experience
ISS / ISE experience
R programming knowledge
Soft Skills
Strong leadership and mentoring ability
Excellent communication skills
Strong problem-solving and analytical thinking
Ability to manage multiple priorities
Attention to detail and regulatory awareness
Preferred Qualifications
Experience with global clinical submissions
Participation in standards organizations (CDISC-related)
Experience in automation or macro development
Strong understanding of clinical drug development lifecycle
Work Environment
Remote (India-based)
Global clinical trials and regulatory submission environment
High-complexity, deadline-driven programming projects
Cross-functional collaboration with statisticians and regulatory teams
Role Impact
Directly supports clinical trial analysis and regulatory submissions
Ensures data integrity for FDA/EMA submissions
Improves efficiency and standardization in clinical programming
Plays a key leadership role in biometrics delivery teams
Career Progression
This role can lead to:
Associate Director / Director – Statistical Programming
Biostatistics leadership roles
CDISC / Standards SME roles
Clinical Data Science leadership paths
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