Responsibilities and Requirements:
Experience working in various disease areas.
Specific expertise in SDTM programming, submissions experience, and strong skill in graphing.
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.
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.
Ability to communicate effectively within a multi-disciplinary project team to assess priorities and complete assigned tasks on time.
Proficient in SAS programming in a regulated clinical research environment.
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