Job Description
Job Title: Senior Statistical Programmer
Location: IN/EU(Hybrid/Remote)
Employment Type: Full-Time
Experience Required: 7+ Years
Job Summary
We are looking for a strong Senior Statistical Programmer. The role requires hands-on expertise in SAS-based analysis and reporting, CDISC-compliant SDTM and ADa M development, and delivery of high-quality Tables, Listings, and Figures (TLFs) in a regulated clinical research environment.
Key Responsibilities
Perform end-to-end statistical programming for clinical trial data analysis and reporting using SAS.
Lead the development, validation, and maintenance of SDTM and ADa M datasets in compliance with CDISC standards.
Program and validate Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
Support safety and efficacy analyses, including ISS and ISE deliverables.
Develop complex ad-hoc analyses and reports from raw clinical data.
Ensure production-quality programming through independent QC and validation.
Collaborate closely with statisticians, data management, and cross-functional teams.
Demonstrate strong ownership, accountability, and adherence to project timelines.
Adapt effectively to changing priorities in a fast-paced clinical development environment.
Required Qualifications
Bachelor’s or Master’s degree in Life Sciences, Statistics, Computer Science, or a related field.
Minimum 7+ years of hands-on experience in clinical trial statistical programming.
Strong proficiency in SAS (Base SAS, Macros, SAS/STAT, SAS/GRAPH).
Solid experience with CDISC standards (SDTM, ADa M), including mapping, development, and validation.
Experience supporting regulatory submissions, including ISS and ISE.
Familiarity with e CTD deliverables, Define.xml, and dataset documentation.
Strong analytical, problem-solving, and documentation skills.
Ability to work independently and as part of a collaborative team.
Nice to Have
Experience working in global or client-facing project environments.
Exposure to mentoring junior programmers or providing QC oversight.
Prior involvement in submission-driven studies.
Location: IN/EU(Hybrid/Remote)
Employment Type: Full-Time
Experience Required: 7+ Years
Job Summary
We are looking for a strong Senior Statistical Programmer. The role requires hands-on expertise in SAS-based analysis and reporting, CDISC-compliant SDTM and ADa M development, and delivery of high-quality Tables, Listings, and Figures (TLFs) in a regulated clinical research environment.
Key Responsibilities
Perform end-to-end statistical programming for clinical trial data analysis and reporting using SAS.
Lead the development, validation, and maintenance of SDTM and ADa M datasets in compliance with CDISC standards.
Program and validate Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
Support safety and efficacy analyses, including ISS and ISE deliverables.
Develop complex ad-hoc analyses and reports from raw clinical data.
Ensure production-quality programming through independent QC and validation.
Collaborate closely with statisticians, data management, and cross-functional teams.
Demonstrate strong ownership, accountability, and adherence to project timelines.
Adapt effectively to changing priorities in a fast-paced clinical development environment.
Required Qualifications
Bachelor’s or Master’s degree in Life Sciences, Statistics, Computer Science, or a related field.
Minimum 7+ years of hands-on experience in clinical trial statistical programming.
Strong proficiency in SAS (Base SAS, Macros, SAS/STAT, SAS/GRAPH).
Solid experience with CDISC standards (SDTM, ADa M), including mapping, development, and validation.
Experience supporting regulatory submissions, including ISS and ISE.
Familiarity with e CTD deliverables, Define.xml, and dataset documentation.
Strong analytical, problem-solving, and documentation skills.
Ability to work independently and as part of a collaborative team.
Nice to Have
Experience working in global or client-facing project environments.
Exposure to mentoring junior programmers or providing QC oversight.
Prior involvement in submission-driven studies.
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