Statistical Programmer
Statistical Programmer
Posted on :
21-07-2025
Employer Active
1 Vacancy
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Job Description
Responsibilities:
- Lead programming efforts for various clinical studies from Phase 1 to Phase 3 across multiple therapeutic areas.
- Develop and review annotated Case Report Forms (CRFs) and SDTM datasets ensuring accurate data representation.
- Program SDTM ADaM and TLFs and write detailed dataset specifications.
- Perform quality control on datasets and tables ensuring compliance with project requirements.
- Work closely with Clinical Operations Clinical Data Management Drug Safety Regulatory Affairs and Project Management teams to ensure the timely and accurate delivery of statistical programming work.
- Provide technical input on documentation produced by other functions including biostatisticians medical writers and data managers.
- Ensure clear and effective communication regarding project progress timelines and any issues that may impact deliverables.
- Contribute to process improvement initiatives aimed at enhancing efficiency and quality in statistical programming.
- Identify new tools and technologies to optimize the programming workflow and improve deliverable quality.
- Serve as a mentor and role model setting high expectations for quality creativity and ownership across projects.
- Manage competing priorities and foster a collaborative work environment to support project success.
- Masters degree in Statistics Computer Science Mathematics Engineering or a related field.
- 6 years of experience in clinical trial programming within the biotechnology pharmaceutical or healthcare industry.
- Expertise in SAS programming with proficiency in additional statistical software such as R or S-Plus.
- In-depth knowledge of CDISC standards including SDTM ADaM and controlled terminologies.
- Strong organizational skills and the ability to prioritize and manage multiple tasks efficiently.
- Self-motivated technically proficient and able to work independently while maintaining a strategic perspective on statistical programming processes.
- Experience working with cross-functional teams to ensure project alignment and timely execution.
- Knowledge of process improvement strategies within statistical programming is a plus.
Employment Type
Full-time
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