Principal Statistical Programmer

Lifelancer | Career PageJob Openings Principal Statistical Programmer About the job Principal Statistical Programmer Job Title: Principal Statistical Programmer Job Location: Durham, North Carolina, United States of America Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Position SummaryWe are seeking a Principal Statistical Programmer to provide full end‑to‑end statistical programming support across clinical development programs. This role requires deep technical expertise, leadership, and hands‑on delivery, covering SDTM, ADaM, TLF development, and regulatory submission support. The Principal Statistical Programmer will serve as a subject matter expert, ensure high‑quality deliverables, and contribute to programming standards and best practices.Key ResponsibilitiesProvide end‑to‑end statistical programming support for clinical studies from study setup through submissionLead and perform development and validation of:SDTM datasetsADaM datasetsTables, Listings, and Figures (TLFs)Ensure all deliverables are compliant with CDISC standards and regulatory requirementsSupport regulatory submissions (e.g., FDA, EMA), including define.xml, submission‑ready datasets, and reviewer’s guidesServe as a Principal‑level programmer, providing technical leadership and guidance to other programmers as neededContribute to and help maintain programming standards, macros, and validation processesReview and approve programming deliverables to ensure accuracy, consistency, and qualityCollaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teamsProactively identify risks and propose efficient, compliant solutions within timelinesRequired QualificationsBachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related fieldExtensive experience as a statistical programmer, with demonstrated Principal‑level responsibilitiesStrong hands‑on experience with:SDTM and ADaM dataset developmentTLF programmingRegulatory submission deliverablesExpert proficiency in base SAS and Advanced SAS with good hands on SAS MacrosIn‑depth knowledge of CDISC standards, regulatory guidelines, and submission requirementsProven ability to manage complex studies independently from start to finishIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoeIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.The potential base pay range for this role, when annualized, is $98,200.00 - $273,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.This job is curated by Lifelancer. Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please apply via Lifelancer platform to get connected to the application page and to find similar roles. Apply for Position Or refer someone Share Facebook Line LinkedIn X (Formerly Twitter) Whatsapp EmailRemotePrincipal
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Job Title: Principal Statistical Programmer Job Location: Durham, North Carolina, United States of America Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Position SummaryWe are seeking a Principal Statistical Programmer to provide full end‑to‑end statistical programming support across clinical development programs. This role requires deep technical expertise, leadership, and hands‑on delivery, covering SDTM, ADaM, TLF development, and regulatory submission support. The Principal Statistical Programmer will serve as a subject matter expert, ensure high‑quality deliverables, and contribute to programming standards and best practices.Key ResponsibilitiesProvide end‑to‑end statistical programming support for clinical studies from study setup through submissionLead and perform development and validation of:SDTM datasetsADaM datasetsTables, Listings, and Figures (TLFs)Ensure all deliverables are compliant with CDISC standards and regulatory requirementsSupport regulatory submissions (e.g., FDA, EMA), including define.xml, submission‑ready datasets, and reviewer’s guidesServe as a Principal‑level programmer, providing technical leadership and guidance to other programmers as neededContribute to and help maintain programming standards, macros, and validation processesReview and approve programming deliverables to ensure accuracy, consistency, and qualityCollaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teamsProactively identify risks and propose efficient, compliant solutions within timelinesRequired QualificationsBachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related fieldExtensive experience as a statistical programmer, with demonstrated Principal‑level responsibilitiesStrong hands‑on experience with:SDTM and ADaM dataset developmentTLF programmingRegulatory submission deliverablesExpert proficiency in base SAS and Advanced SAS with good hands on SAS MacrosIn‑depth knowledge of CDISC standards, regulatory guidelines, and submission requirementsProven ability to manage complex studies independently from start to finishIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.comIQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoeIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.The potential base pay range for this role, when annualized, is $98,200.00 - $273,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.This job is curated by Lifelancer. Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

Job Title: Principal Statistical Programmer

Job Title:

Job Location: Durham, North Carolina, United States of America

Job Location:

Job Location Type: Remote

Job Location Type:

Job Contract Type: Full-time

Job Contract Type:

Job Seniority Level:

Job Seniority Level:

Position Summary

Position Summary

We are seeking a Principal Statistical Programmer to provide full end‑to‑end statistical programming support across clinical development programs. This role requires deep technical expertise, leadership, and hands‑on delivery, covering SDTM, ADaM, TLF development, and regulatory submission support. The Principal Statistical Programmer will serve as a subject matter expert, ensure high‑quality deliverables, and contribute to programming standards and best practices.

Principal Statistical Programmerfull end‑to‑end statistical programming supportSDTM, ADaM, TLF development, and regulatory submission support

Key Responsibilities

Key Responsibilities
  • Provide end‑to‑end statistical programming support for clinical studies from study setup through submission

Provide end‑to‑end statistical programming support for clinical studies from study setup through submission

end‑to‑end statistical programming support
  • Lead and perform development and validation of:SDTM datasetsADaM datasetsTables, Listings, and Figures (TLFs)

Lead and perform development and validation of:

  • SDTM datasets

SDTM datasets

SDTM datasets
  • ADaM datasets

ADaM datasets

ADaM datasets
  • Tables, Listings, and Figures (TLFs)

Tables, Listings, and Figures (TLFs)

Tables, Listings, and Figures (TLFs)
  • Ensure all deliverables are compliant with CDISC standards and regulatory requirements

Ensure all deliverables are compliant with CDISC standards and regulatory requirements

CDISC standards
  • Support regulatory submissions (e.g., FDA, EMA), including define.xml, submission‑ready datasets, and reviewer’s guides

Support regulatory submissions (e.g., FDA, EMA), including define.xml, submission‑ready datasets, and reviewer’s guides

regulatory submissions
  • Serve as a Principal‑level programmer, providing technical leadership and guidance to other programmers as needed

Serve as a Principal‑level programmer, providing technical leadership and guidance to other programmers as needed

Principal‑level programmer
  • Contribute to and help maintain programming standards, macros, and validation processes

Contribute to and help maintain programming standards, macros, and validation processes

programming standards, macros, and validation processes
  • Review and approve programming deliverables to ensure accuracy, consistency, and quality

Review and approve programming deliverables to ensure accuracy, consistency, and quality

  • Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams

Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams

  • Proactively identify risks and propose efficient, compliant solutions within timelines

Proactively identify risks and propose efficient, compliant solutions within timelines

Required Qualifications

Required Qualifications
  • Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field

Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field

  • Extensive experience as a statistical programmer, with demonstrated Principal‑level responsibilities

Extensive experience as a statistical programmer, with demonstrated Principal‑level responsibilities

statistical programmerPrincipal‑level responsibilities
  • Strong hands‑on experience with:SDTM and ADaM dataset developmentTLF programmingRegulatory submission deliverables

Strong hands‑on experience with:

  • SDTM and ADaM dataset development

SDTM and ADaM dataset development

SDTM and ADaM
  • TLF programming

TLF programming

TLF programming
  • Regulatory submission deliverables

Regulatory submission deliverables

Regulatory submission deliverables
  • Expert proficiency in base SAS and Advanced SAS with good hands on SAS Macros

Expert proficiency in base SAS and Advanced SAS with good hands on SAS Macros

and Advanced SAS with good hands on SAS Macros
  • In‑depth knowledge of CDISC standards, regulatory guidelines, and submission requirements

In‑depth knowledge of CDISC standards, regulatory guidelines, and submission requirements

CDISC standards
  • Proven ability to manage complex studies independently from start to finish

Proven ability to manage complex studies independently from start to finish

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

This job is curated by Lifelancer.

This job is curated by Lifelancer.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.

Please apply via Lifelancer platform to get connected to the application page and to find similar roles.