Job Description
Role Summary
We are seeking a highly experienced Senior / Lead Statistical Programmer for a part-time engagement to support clinical trial programming activities within a CRO environment. This role is ideal for seasoned professionals who can provide deep technical expertise, quality oversight, and delivery leadership on a flexible schedule.
The role focuses on advanced SAS programming, CDISC compliance, regulatory-ready deliverables, and close collaboration with biostatistics and cross-functional teams.
Key Responsibilities
Lead and execute statistical programming activities for one or more clinical studies on a part-time basis
Develop, review, and optimize SAS programs for clinical trial data analysis
Oversee creation and validation of SDTM and ADaM datasets in compliance with CDISC standards
Generate and review Tables, Listings, and Figures (TLFs) for interim, final, and regulatory submissions
Support interim analyses, final analyses, Clinical Study Reports (CSRs), and regulatory deliverables
Perform and oversee QC, independent validation, and peer review of programming outputs
Provide technical guidance and mentoring to junior programmers as needed
Collaborate closely with biostatisticians to ensure accurate implementation of statistical analysis plans
Ensure adherence to SOPs, GxP guidelines, and regulatory requirements
Maintain complete programming documentation, traceability, and version control
Support audits, inspections, and sponsor queries related to statistical programming
Required Skills & Experience
10–15 years of hands-on experience in statistical programming within a CRO or regulated clinical research environment
Strong expertise in SAS (Base SAS, Macros; SAS/STAT preferred)
Advanced working knowledge of CDISC standards (SDTM, ADaM)
Proven experience supporting Phase I–IV clinical trials
Strong understanding of the clinical trial lifecycle and regulatory expectations
Experience supporting FDA, EMA, or other global regulatory submissions
Ability to work independently with minimal supervision in a part-time setup
Strong analytical, problem-solving, and communication skills
We are seeking a highly experienced Senior / Lead Statistical Programmer for a part-time engagement to support clinical trial programming activities within a CRO environment. This role is ideal for seasoned professionals who can provide deep technical expertise, quality oversight, and delivery leadership on a flexible schedule.
The role focuses on advanced SAS programming, CDISC compliance, regulatory-ready deliverables, and close collaboration with biostatistics and cross-functional teams.
Key Responsibilities
Lead and execute statistical programming activities for one or more clinical studies on a part-time basis
Develop, review, and optimize SAS programs for clinical trial data analysis
Oversee creation and validation of SDTM and ADaM datasets in compliance with CDISC standards
Generate and review Tables, Listings, and Figures (TLFs) for interim, final, and regulatory submissions
Support interim analyses, final analyses, Clinical Study Reports (CSRs), and regulatory deliverables
Perform and oversee QC, independent validation, and peer review of programming outputs
Provide technical guidance and mentoring to junior programmers as needed
Collaborate closely with biostatisticians to ensure accurate implementation of statistical analysis plans
Ensure adherence to SOPs, GxP guidelines, and regulatory requirements
Maintain complete programming documentation, traceability, and version control
Support audits, inspections, and sponsor queries related to statistical programming
Required Skills & Experience
10–15 years of hands-on experience in statistical programming within a CRO or regulated clinical research environment
Strong expertise in SAS (Base SAS, Macros; SAS/STAT preferred)
Advanced working knowledge of CDISC standards (SDTM, ADaM)
Proven experience supporting Phase I–IV clinical trials
Strong understanding of the clinical trial lifecycle and regulatory expectations
Experience supporting FDA, EMA, or other global regulatory submissions
Ability to work independently with minimal supervision in a part-time setup
Strong analytical, problem-solving, and communication skills
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