Job Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

• Hands on statistical programming experience in the pharma/biotech industry
• Strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, and SAS Macros, preferrable experience using R. 
• Desire to understand the disease area, protocol, SAP, and study related documents.
• Good knowledge of clinical trial design, and statistical terminology.
• Strong knowledge of CDISC SDTM and ADaM data models.
• Demonstrated proficiency in developing dataset specifications, and using SAS/R to produce SDTM datasets, ADaM datasets, and TFLs.
• Thorough understanding of clinical data structures, and data exchange with multiple data formats.
• Expertise in performing validation of datasets, and TFLs using risk-based approach.
• Expertise in regulatory submissions, preparation of e-sub package.
• In-depth understanding of regulatory, industry, and technology standards and requirements.
• Exceptional organizational, communication and time management skills, with the ability to multi-task across projects. 
• Demonstrated ability to work in a team environment with cross-functional teams.

Qualifications

• Strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, and SAS Macros, preferrable experience using R.
• Strong knowledge of CDISC SDTM and ADaM data models.
• Demonstrated proficiency in developing dataset specifications, and using SAS/R to produce SDTM datasets, ADaM datasets, and TFLs.
• Expertise in regulatory Submissions.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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