Job Title
Lead Statistical Programmer – Clinical Pharmacology (CP Studies)
Experience: 4+ Years
Work Mode: Office or Home (as per manager approval)
Travel Requirement: ~5% (mostly client meetings & trainings, may involve overnight stays)
Job Overview
This role involves leading statistical programming activities for Clinical Pharmacology (CP) studies.
You will act as a Lead Statistical Programmer, responsible for planning, executing, and overseeing all programming deliverables while ensuring quality, timelines, and compliance with regulatory standards.
The role requires collaboration with internal teams and clients, along with support from senior programming staff when needed.
Key Responsibilities
1. Study Programming Leadership
Lead statistical programming activities for assigned clinical studies
Plan and manage:
Programming resources
Timelines
Budget adherence
Quality standards
Coordinate with cross-functional teams and clients
2. SAS Programming & Dataset Development
Develop and maintain SAS programs for:
SDTM datasets
ADaM datasets
Tables, Listings, and Figures (TFLs)
Perform QC (Quality Control) of:
SDTM datasets
ADaM datasets
TFL outputs
3. Clinical Data Standards (CDISC)
Ensure compliance with CDISC standards
Develop specifications for SDTM and ADaM datasets (with senior support)
Apply standardization principles in clinical datasets
4. Regulatory & Submission Support
Create submission deliverables including:
Define XML/PDF files
Analysis Results Metadata (ARM)
Annotated eCRFs
Review Guides
5. Documentation & Review Support
Review Statistical Analysis Plans (SAPs) and TFL shells from a programming perspective
Support audit responses (QA and client audits) with senior guidance
6. Collaboration & Communication
Interact with:
Internal programming teams
Cross-functional departments
External clients
Ensure smooth communication of programming deliverables and expectations
7. Quality & Compliance
Ensure high-quality programming outputs
Follow regulatory and industry standards
Support continuous improvement in programming processes
8. Additional Responsibilities
Perform any other duties as assigned
Support senior programmers in complex technical tasks
Required Qualifications
Bachelor’s degree in:
Mathematics
Statistics
Computer Science
Life Sciences
Health Sciences
Or related field
OR
Equivalent education and relevant work experience
Experience Required
Minimum 4+ years of SAS programming experience
Experience in:
CRO or Pharmaceutical industry
Strong knowledge of:
CDISC standards (SDTM, ADaM)
Equivalent education + experience may be considered
Skills Required
Strong SAS programming expertise
Knowledge of clinical data standards
Ability to manage multiple study deliverables
Strong analytical and problem-solving skills
Good communication and teamwork abilities
Ability to work under timelines and budget constraints
Language Requirements
English (Required):
Reading
Writing
Speaking
Work Environment
Office-based or remote (as per manager approval)
Global clinical trial environment
Collaboration with clients and cross-functional teams
Exposure to regulatory submission workflows
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