Minimum of 5 years of programming experience in the pharmaceutical or biotech industries.
Expertise in SDTM programming with the ability to create specifications from scratch.
Experience in creating ADaM datasets and associated documentation.
Proficient in using SAS software for regulatory submissions and data management.
Comfortable working independently while being an active contributor in team discussions.
Familiarity with crafting source and validation programs for SDTM datasets and TLGs.
Experience in various disease therapeutic areas is required; rare disease experience is a plus.
Responsibilities
Develop and implement SDTM specifications and datasets from the ground up.
Create and validate analysis datasets, tables, listings, and graphs for multiple studies.
Execute programming tasks using SAS software for clinical regulatory submissions.
Actively communicate and collaborate with project team members to meet deadlines.
Ensure compliance with regulatory requirements throughout the programming process.
Support project work by offering insights and recommendations based on expertise.
Provide independent contributions while maintaining attention to detail in all tasks.
Benefits
Opportunity to work in a dynamic and collaborative team environment.
Engagement with cutting-edge projects in the field of rare diseases.
Professional development opportunities in specialized therapeutic areas.
Full 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.
