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Senior Statistical Programmer

Company

Simelabs - Digital, AI/ML, Automation, Robotics, Gen AI.

Location

Mumbai, Maharashtra

Type

Full-time

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 working , including sprint planning, backlog management, and co...

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