Senior Statistical Programmer/Analyst Consultant
About the role
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? Our team says it's the best of both worlds...
ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients.
The Senior 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.
Key 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.
Required Qualifications
- Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
- 6–10+ 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.
Vacancy: This posting is for an existing vacancy.
Open Date: 02/27/2026 Close Date: 03/27/2026 The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following & delete these instructions): ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301. We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection. The base salary pay range represents the anticipated low and high range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
Canada Pay Range
$60—$80 CAD
About ClinChoice
ClinChoice is a full-service global clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide. With a 25 year history of success, ClinChoice continues to be The Standard of Excellence for biostatistics, clinical operations, data management, statistical programming, CDISC, regulatory affairs, medical affairs and pharmacovigilance. ClinChoice has established major delivery centers across US, China, Europe, Canada, India, Japan and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America and Europe.
Senior Statistical Programmer/Analyst Consultant
About the role
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? Our team says it's the best of both worlds...
ClinChoice is searching for a Senior Statistical Programmer Consultant to join one of our clients.
The Senior 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.
Key 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.
Required Qualifications
- Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
- 6–10+ 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.
Vacancy: This posting is for an existing vacancy.
Open Date: 02/27/2026 Close Date: 03/27/2026 The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following & delete these instructions): ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301. We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection. The base salary pay range represents the anticipated low and high range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
Canada Pay Range
$60—$80 CAD
About ClinChoice
ClinChoice is a full-service global clinical CRO dedicated to offering high-quality, efficient and flexible solutions to pharmaceutical, biotechnology, medical device, and consumer products clients worldwide. With a 25 year history of success, ClinChoice continues to be The Standard of Excellence for biostatistics, clinical operations, data management, statistical programming, CDISC, regulatory affairs, medical affairs and pharmacovigilance. ClinChoice has established major delivery centers across US, China, Europe, Canada, India, Japan and the Philippines. It has over 4,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America and Europe.