Senior / Principal Statistical Programmer – ADaM / TLF (Oncology)
Location: India – Remote
Updated: Yesterday
Job ID: 25102640
Company: Syneos Health®
About Syneos Health®
Syneos Health is a global biopharmaceutical solutions organization with 29,000 employees across 110 countries, working to accelerate the development and delivery of innovative therapies.
We put patients at the center of our Clinical Development model and strive to simplify processes to create a better experience for both clients and employees.
Role Overview
The Senior/Principal Statistical Programmer will develop and validate statistical programs to support clinical trial analysis, primarily using SAS, with a strong focus on ADaM datasets, TLF generation, and Oncology studies.
Immediate joiners preferred.
Key Responsibilities
Programming & Data Development
Develop custom SAS programs to generate ADaM datasets, summary tables, listings, figures (TLFs) based on Statistical Analysis Plans (SAPs) and programming specifications.
Perform validation programming and resolve discrepancies with Biostatisticians, Programmers, and the project team.
Ensure all outputs meet quality standards, regulatory guidelines (ICH), SOPs, and sponsor requirements.
Documentation & Quality
Maintain complete, organized, inspection-ready documentation for programming, testing, and QC.
Develop dataset and output specifications of any complexity with clear variable definitions.
Project Delivery & Collaboration
Manage timelines across multiple projects; adjust workload based on priorities.
Provide accurate time estimates and complete programming activities within agreed timelines.
Lead internal meetings, contribute effectively, and follow through on all action items.
Leadership & Oversight (Lead Programmer Role)
Act as Lead Statistical Programmer for assigned studies.
Guide and review the work of other programmers.
Review SAPs, mock shells, annotated CRFs, datasets specifications and provide constructive feedback.
Participate in sponsor meetings, kick-off meetings, and bid-defense presentations.
Training & Mentoring
Mentor junior programmers, conduct training sessions, review work, and support onboarding.
Contribute to process improvements and knowledge sharing across the team.
Other
Perform additional job-related duties as assigned.
Minimal travel may be required.
Required Qualifications
5+ years of experience in Clinical SAS Programming.
Strong expertise in:
Base SAS & Advanced SAS
ADaM dataset creation
TLF programming
Programming specifications development
Hands-on experience with Safety & Efficacy datasets and Oncology therapeutic area.
Preferable: ISS/ISE experience, R Programming.
Excellent verbal & written communication skills.
Ability to work independently and cross-functionally in English.
Immediate joiners preferred.
Summary of the Role
Statistical Programmers at Syneos Health create, validate, and maintain statistical programs to produce analysis datasets and outputs used by statisticians and sponsors. The role includes improving programming processes, supporting study deliverables, and occasionally directing other team members. This position requires deep domain knowledge and the ability to manage entire programming workflows for assigned projects.
How to Apply
Apply via the Syneos Health careers portal.
If not ready to apply, join the Talent Network to receive future updates.
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