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About the role
- Junior Statistical Programmer supporting SAS/R clinical trial programming at ClinChoice, a global full-service CRO. Developing validated CDISC datasets and regulatory submission deliverables.
Responsibilities
- Support the development and validation of datasets, tables, figures, and listings for clinical trials.
- Perform programming activities using SAS and/or R under appropriate guidance and review.
- Assist with processing and integrating data from internal and external sources.
- Support ad hoc analyses and programming activities for clinical development and other Research & Development functions.
- Assist with the development, review, and maintenance of programming specifications and documentation.
- Contribute to the development and review of SDTM and ADaM datasets and specifications.
- Support the preparation and review of Define-XML and other clinical trial documentation.
- Work closely with Senior Statistical Programmers, Biostatisticians, Data Managers, and other cross-functional team members.
- Support the programming and validation of CDISC-compliant datasets and deliverables for regulatory submissions.
- Assist with the preparation of supporting documentation for electronic submissions.
- Ensure programming outputs follow applicable standards, specifications, and quality requirements.
- Perform programming validation and quality checks according to established procedures.
- Identify, document, and resolve programming issues in collaboration with senior team members.
- Ensure assigned deliverables are completed accurately and within agreed timelines.
- Follow departmental programming standards, working instructions, and applicable industry guidelines.
- Develop knowledge of CDISC standards, including SDTM and ADaM.
- Assist in maintaining and improving programming macros, utilities, and reusable functions.
Requirements
- Bachelor's or Master's degree in Computer Science, Statistics, Mathematics, Engineering, Life Sciences, or a related discipline.
- 0–2 years of experience in statistical programming, preferably within the pharmaceutical, biotechnology, CRO, or clinical research industry.
- Basic to intermediate knowledge of SAS and/or R.
- Familiarity with SAS programming and SAS Macro language is preferred.
- Basic understanding of clinical trial data and the drug development process.
- Knowledge or exposure to CDISC standards, SDTM, and ADaM is preferred.
- Familiarity with clinical trial datasets, tables, figures, and listings is an advantage.
- Strong attention to detail and commitment to data quality.
- Ability to work effectively in a team environment and learn from senior team members.
- Ability to manage assigned tasks and meet project timelines.
Benefits
- Equal opportunity employer
- Inclusive, barrier-free recruitment and selection processes
- Accommodation for qualified applicants under the Human Rights Code and Accessibility for Ontarians Disabilities Act
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