Job Description

Ridgefield, CT


Contract Duration: 24-36 months


Rate: Negotiable


Salary: NA $1.00


Responsibilities:

• Excellent employment opportunity for a SAS Programmer II in the Ridgefield, CT area.
• Compile and validate pooled databases on a regular basis, or ad-hoc, as per standard procedures, using validated tools.
• Execute data checks each time pooled database is updated with new data.
• Maintain and upgrade to latest MEDDra and WHO-DD drug versions in pooled databases, updating and validating as needed.
• Create and maintain SAS programs to support CDISC SDTM data validation on clinical trial databases (e.g. required fields, correct format, across record logic checks).
• Collaborate with Data Manager to identify enhancements or additional checks for both trial and project level.
• Run/Review Pinnacle 21 Validator/Enterprise on trial or pooled data and troubleshoot findings with trial team.
• Responsible for documentation to support the validation of SAS programs.
• Provide input on mapping specifications from source EDC to SDTM structure.
• Suggest process improvements to increase speed and/or efficiency.
• May assist with other data management deliverables, e.g. creating data cleaning/QC SAS programs.
• Maintain libraries of fully documented and validated programs, macros and procedure, which are adaptable/reusable across trials.

• Bachelor's Degree in Math, IT or Life Sciences.
• Advanced SAS Certification - can be verified via the Public Registry of SAS Certified Professionals or equivalent industry experience.
• Minimum of 3 - 5 years of experience in SAS programming within clinical data management at a Biotech, Pharmaceutical, or CRO company.
• Proficiency with CDISC and SDTM data structures and the Pinnacle 21 Validator/Enterprise.
• Additional experience with Oracle Clinical and Medidata RAVE is preferred or other industry EDC systems will be considered.
• Organizational skills, problem-solving abilities, time management skills.
• Ability to multi task.
• Must be able to work independently as well as part of a team.
• Good written and oral communications skills in the English language.
• Must be precise, detail oriented, and able to detect subtle inconsistencies in the data.

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