Principal Statistical Programmer /Analyst Consultant - Remote in US
ClinChoice, Rahway, NJ, United States
Overview
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? ClinChoice is searching for a
Principal Statistical Programmer Consultant
to join one of our clients. The
Principal Statistical Programmer
will serve as a senior technical expert responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors. This role requires advanced expertise in
SAS , familiarity with
R , deep knowledge of
CDISC standards , and strong experience working on oncology studies and regulatory submissions.
Responsibilities Technical Leadership
Lead programming activities for oncology clinical trials across multiple studies.
Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines.
Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions.
Provide SAS programming expertise to support complex data derivations and analyses.
Review and ensure traceability, consistency, and quality of all programming deliverables.
Project & Study Management
Act as programming lead for assigned studies, managing timelines and deliverables.
Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs.
Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards.
Support integrated analyses including ISS/ISE.
Regulatory & Submission Support
Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.
Ensure all programming meets regulatory requirements (FDA, EMA, PMDA).
Contribute to responses for regulatory queries and data requests.
Qualifications
Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
8–12+ years of statistical programming experience in pharma/biotech or CRO.
Expert-level proficiency in SAS.
Strong understanding of CDISC SDTM and ADaM standards.
Significant experience supporting oncology clinical trials (hematologic or solid tumors).
Experience supporting regulatory submissions and preparing submission-ready outputs.
Excellent communication skills and ability to collaborate cross-functionally.
EEO Statement ClinChoice is an equal opportunity employer. We value diversity and inclusivity and do not discriminate on the basis of gender, race, beliefs, or ethnicity.
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Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? ClinChoice is searching for a
Principal Statistical Programmer Consultant
to join one of our clients. The
Principal Statistical Programmer
will serve as a senior technical expert responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors. This role requires advanced expertise in
SAS , familiarity with
R , deep knowledge of
CDISC standards , and strong experience working on oncology studies and regulatory submissions.
Responsibilities Technical Leadership
Lead programming activities for oncology clinical trials across multiple studies.
Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines.
Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions.
Provide SAS programming expertise to support complex data derivations and analyses.
Review and ensure traceability, consistency, and quality of all programming deliverables.
Project & Study Management
Act as programming lead for assigned studies, managing timelines and deliverables.
Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs.
Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to client programming standards.
Support integrated analyses including ISS/ISE.
Regulatory & Submission Support
Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides.
Ensure all programming meets regulatory requirements (FDA, EMA, PMDA).
Contribute to responses for regulatory queries and data requests.
Qualifications
Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
8–12+ years of statistical programming experience in pharma/biotech or CRO.
Expert-level proficiency in SAS.
Strong understanding of CDISC SDTM and ADaM standards.
Significant experience supporting oncology clinical trials (hematologic or solid tumors).
Experience supporting regulatory submissions and preparing submission-ready outputs.
Excellent communication skills and ability to collaborate cross-functionally.
EEO Statement ClinChoice is an equal opportunity employer. We value diversity and inclusivity and do not discriminate on the basis of gender, race, beliefs, or ethnicity.
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