Senior Statistical Programmer / Principal Statistical Programmer (PK/PD Programming)
Company: Syneos Health
Location: IND – Remote
Job ID: 25107313
Updated On: May 8, 2026
Experience Level: 5+ years
Company Overview
Syneos Health is a global life sciences services organization focused on accelerating clinical development and commercialization. It partners with pharmaceutical companies to deliver end-to-end clinical, statistical, and regulatory solutions across drug development programs.
Role Summary
The Senior / Principal Statistical Programmer (PK/PD Programming) is responsible for:
Developing and validating PK/PD analysis datasets and outputs
Supporting pharmacokinetic and pharmacodynamic data analysis programming
Generating TLFs (Tables, Listings, Figures) for PK reporting
Acting as a subject matter expert in PK programming workflows and CDISC standards
Key Responsibilities
1. Statistical Programming & PK/PD Data Development
Use SAS and R to develop programming code for:
Tables
Listings
Figures (TLFs)
Analysis datasets
Build PK-specific datasets such as:
ADPC (Pharmacokinetic Concentration Dataset)
ADNCA (NCA Analysis Dataset)
ADPP (Pharmacodynamic Dataset)
2. Validation & Quality Control
Perform validation programming for PK/PD outputs
Resolve discrepancies with statisticians and clinical teams
Ensure outputs meet sponsor and regulatory requirements
Maintain inspection-ready documentation
3. PK/PD Analysis Support
Support NONMEM dataset preparation
Work with NCA (Non-Compartmental Analysis) datasets
Ensure correct implementation of PK workflows across study designs
4. Cross-Functional Collaboration
Collaborate with:
Clinical Pharmacologists
Statisticians
Study Lead Programmers
Translate statistical and PK requirements into programming deliverables
Participate in sponsor meetings and study discussions
5. Standards & Compliance
Follow SOPs, WIs, and regulatory guidelines (e.g., ICH)
Ensure CDISC compliance across PK datasets
Maintain structured and auditable documentation
6. Project Management & Delivery
Manage timelines across multiple programming projects
Prioritize tasks and adjust workload based on changing demands
Ensure on-time delivery of programming outputs
Communicate risks and progress to stakeholders
7. Leadership & Mentoring
Act as lead or senior programmer on PK projects
Guide junior programmers and review their work
Contribute to training materials and knowledge sharing
Provide feedback to improve efficiency and reduce rework
8. Meetings & Communication
Conduct and participate in internal and sponsor meetings
Share updates, documentation, and meeting minutes
Ensure follow-up on action items and deliverables
Maintain clarity in communication of complex PK concepts
Required Skills & Expertise
Technical Skills
5+ years in clinical statistical programming
Strong expertise in:
SAS programming
Intermediate/advanced R programming
CDISC standards
Experience in:
PK/PD workflows
NONMEM datasets
NCA datasets
Experience generating PK TLFs and analysis datasets
Domain Expertise
Strong understanding of pharmacokinetics (PK)
Knowledge of pharmacodynamic analysis workflows
Experience across different clinical study designs
Soft Skills
Strong analytical and problem-solving skills
Ability to communicate complex technical concepts clearly
Leadership and mentoring capability
Strong collaboration with cross-functional teams
Ability to manage multiple priorities
Preferred Competencies
Experience in global clinical submissions
Exposure to regulatory submission environments
Automation or macro development experience
Strong understanding of clinical drug development lifecycle
Work Environment
Remote (India-based)
Global clinical pharmacology and statistical programming teams
High complexity, deadline-driven environment
Strong collaboration with clinical and statistical scientists
Role Impact
Enables accurate PK/PD analysis for clinical trials
Directly supports regulatory submissions and drug development decisions
Improves efficiency and standardization in PK programming
Contributes to evidence generation for drug safety and efficacy
Career Progression
This role can lead to:
Associate Director / Director – Statistical Programming
PK/PD Lead Programmer roles
Clinical Pharmacology Data Science roles
Biometrics leadership positions
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