Exelo technology
Website:
exelotech.com
Job details:
Role : Senior Statistical Programmer
Location – Remote
Contract length – 1 year
Interview – 2 rounds, virtual
Key requirements for the role:
Candidates must have good hands-on experience with ADaM, and TFL programming, covering both safety and efficacy.
Prior experience with R programming will be preferred/an added advantage.
Roles and Responsibilities –
- Contribute to or lead statistical programming activities for Phase I to IV clinical trials.
- Develop and validate datasets, tables, listings, and figures (TFLs) as per specifications.
- Build and maintain effective working relationships with cross-functional teams (biostatistics, data management, clinical teams).
- Participate in team meetings and communicate programming progress and issues.
- Adhere to company, departmental, and industry standards (CDISC SDTM/ADaM, GCP).
- Ensure audit readiness and compliance with regulatory requirements.
- Review or develop programming specifications as part of statistical analysis plans.
- Participate in or lead the review of eCRFs and data structures.
- Ensure accuracy, reliability, and quality of statistical analysis results; perform QC checks on deliverables.
- Use SAS and other statistical programming tools (R) effectively.
- Mentor and guide junior programmers; contribute to process improvement and standardization initiatives.
- Lead programming for studies/project-level activities; coordinate other programmers on the study/project.
- Ensure quality and timely deliverables for study-level milestones (DMCs, IAs, Publications, CSRs, submissions, etc.).
Experience/Professional Requirements:
- 7–10 years of experience.
- Proven ability to deliver quality outputs and coordinate teams.
- Strong knowledge of CDISC and regulatory frameworks.
- Good understanding of regulatory requirements (GCP, ICH, etc.).
- Excellent communication and collaboration skills.
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