Job Description

Responsibilities and Requirements:

Experience working in various disease areas.
They also must have specific expertise in SDTM programming, have submissions experience, and MUST possess strong skill in graphing.
They need to be comfortable working as a strong independent contributor who is attentive and speaks up throughout the project work.

Minimum of 5 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.
The ideal candidate must be able to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
Proficient of SAS programming in a regulated clinical research environment.

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