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Senior Statistical programmer

Remote:

Full Remote

Experience:

Mid-level (2-5 years)

Work from:

Offer summary

Minimum 12+ years in pharmaceutical/biotech industries, Expertise in SDTM and submissions experience.

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

Responsibilities:

experience working in various disease areas (not just oncology).
They also must have specific expertise in SDTM programming, have submissions experience, and MUST possess strong skill in graphs.
They need to be comfortable working as a strong independent contributor who is attentive and speaks up throughout the project work.

Requirements:

Minimum of 12+ years programming experience in the pharmaceutical/biotech industries
Experience working in various disease therapeutic areas is required.
Must have strong SDTM programming skills, ability to create SDTM specifications from scratch and be comfortable with creating ADaM datasets.
Experience creating source and validation programs using SAS software for SDTM datasets, analysis datasets, and tables, listings, and graphs (TLGs) for multiple studies/products.
Regulatory submissions experience
Rare disease TA experience is highly preferred; Gene Therapy exp is also a plus.
Needs to be a strong remote-worker and maintain excellent, consistent communication with the team.