
Leading Clinical Statistical Programming Specialist
1 day ago
Job Description:
- Work as a senior clinical statistical programmer on large-scale complex projects.
Key Responsibilities:
- Lead the development of analysis-ready datasets, tables, listings, and figures.
- Participate in the review of Case Report Forms (CRFs), CRF annotations, Statistical Analysis Plans, SDTM/ADAM specifications, datasets, and TLFs.
- Ensure all statistical activities are in accordance with internal and external quality standards, SOPs/WPDs, ICH-GCP, and/or other international/local regulatory requirements.
- Collaborate with cross-functional teams to deliver high-quality results.
- Provide guidance and mentorship to junior team members.
Required Skills and Qualifications:
- 5+ years of experience in statistical programming, preferably in the pharmaceutical industry.
- Strong oral and written communication skills.
- Hands-on experience with SAS, CDISC, and other programming languages.
- Knowledge of regulatory guidelines, such as ICH-GCP and 21 CFR Part 11.
- Ability to work in a fast-paced environment and meet deadlines.
Benefits:
- Opportunity to work on diverse projects and develop expertise in multiple areas.
- Professional growth and development through training and mentorship programs.
- Collaborative and dynamic work environment.
Others:
- Relevant industry experience is mandatory. Freshers may kindly refrain from applying.
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