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Senior Statistical Programmer
Simelabs - Digital, AI/ML, Automation, Robotics, Gen AI. • Mumbai, India
About the Role
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...
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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