Job Description
JD:
Required Skills
- Strong programming expertise in R Programming with the ability to upskill to a proficient level quickly.
- Hands-on experience in ADaM dataset creation and TLF (Tables, Listings & Figures) programming .
- Good understanding of clinical trial data standards and regulatory requirements.
- Ability to perform data validation, quality checks, and support statistical analysis activities.
- Experience working with clinical study teams, biostatisticians, and data management teams.
- Strong analytical, problem-solving, and communication skills.
Preferred Skills
- Advanced to expert-level knowledge in R Programming .
- Experience in:
- ISS/ISE (Integrated Summary of Safety / Integrated Summary of Efficacy)
- Regulatory Submissions
- RTQs (Regulatory/Reviewer Query support)
- Familiarity with Agile ways of ...