Senior Manager - Statistical Programming, Central Services

Regeneron · Hyderabad

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What they're looking for

8+ years statistical programming experience in pharmaceutical, biotech, or clinical research with leadership background
Advanced SAS programming proficiency with CDISC standards knowledge (SDTM, ADaM, Define-XML)
Demonstrated experience supporting FDA, EMA, PMDA regulatory submissions
Strong clinical trial data and regulatory reporting process expertise
Bachelor's degree in relevant field
Fluent English with cross-functional global team collaboration ability

What you'll be doing

Lead statistical programming activities across clinical programs and assigned regions
Develop integrated datasets and analysis outputs for clinical studies and regulatory submissions
Coordinate preparation and review of electronic submission packages (eCTD) for global regulators
Drive process improvements and compliance enhancements across programming functions
Mentor team members and build capability within the statistical programming function

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RoleLantern checked active

RoleLantern checkedNeeds clarity

Date posted4 days ago

Last source check1 day ago

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