Job Description

• 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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