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 ...