Minimum 6 years of SAS programming experience in clinical trials (CRO or pharmaceutical).
4+ years of expertise in ADaM dataset creation and validation.
Proficient in creating ADaM data specifications (ADSL, ADAE, etc.).
Experience with Tables, Listings, and Figures using proc report or data _null_.
Understanding of regulatory submission processes for ISS, ISE ADaM datasets is a plus.
Skilled in Microsoft Excel and Word.
Strong communication skills required.
Experience in Immunology preferred; candidates from other therapeutic areas considered.
Responsibilities
Support Phase 1-3 clinical trials with SAS programming expertise.
Create and validate ADaM datasets for clinical study compliance.
Develop ADaM data specifications in alignment with industry standards.
Generate Tables, Listings, and Figures for clinical study reports.
Contribute to the regulatory submission process with dataset preparation.
Full Job Description
Job Description
Minimum 6 Years SAS Programming Experience supporting Phase 1-3 clinical trials in CRO or pharmaceutical industry.
Solid understanding of SDTM and ADaM implementation guidance, minimum 4 years of work experience on creating and validating ADaM datasets.
Experience with creating ADaM data specifications; such as ADSL, ADAE, BDS, controlled terminology, etc.
Experience on creating Tables, Listing and Figures for clinical study report using proc report or data _null_.
Knowledge of regulatory submission process, experience on creating ISS, ISE ADaM datasets and TLFs is a plus.
Efficient in using Excel and Word documents.
Excellent communication skill.
Experience in Immunology therapeutic area is preferred, A strong candidate, with experience in another TA, will certainly be considered.
Education - BS in Statistics, Computer Science or a related field with 6+ years of relevant experience OR MS in Statistics, Computer Science or a related field with 4+ years of relevant experience
