What are the responsibilities and job description for the Sr. SAS Programmer position at Katalyst Healthcares & Life Sciences?
Company 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
Responsibilities:
- Lead the development and implementation of submission-ready SDTM datasets in accordance with regulatory requirements (e.g., FDA, EMA, PMDA).
- Collaborate with regulatory affairs and quality assurance teams to ensure compliance with submission guidelines and standards.
- Perform thorough quality control checks to validate the accuracy and completeness of submission datasets.
- Coordinate the preparation and documentation of submission packages, including data specifications and validation documentation.
- Serve as a subject matter expert on submission-related matters, providing guidance and support to cross-functional teams.
- Stay abreast of evolving regulatory requirements and industry best practices realeted.
to SDTM and submission standards.
Requirements:
- Bachelor's or master's degree in a relevant field (e.g., Computer Science, Biostatistics, Life Sciences).
- Minimum of 8 years of experience in Statistical & Clinical programming, with a focus on submission expertise, within the pharmaceutical or biotechnology industry.
- Proficiency in programming languages such as SAS and R.
- Strong knowledge in Windows and UNIX environment, with proficiency in SAS/Base, SAS Macros, SAS/Graph, SAS/SQL, SAS Grid, SAS Enterprise Guide, CDISC, SDTM, MedDRA, WHO DRUG;
- Deep understanding of CDISC standards and regulatory submission requirements.
- Proven experience in preparing and submitting SDTM datasets for regulatory filings (e.g., IND, NDA, BLA).
- Excellent communication and collaboration skills, with the ability to work effectively in a cross-functional environment.
- Strong attention to detail and a commitment to ensuring the quality and integrity of submission datasets.
- Experience with EDC systems (e.g., Medidata Rave, Oracle Clinical) and other tools (Jreview, Spotfire, Tableau) is a plus.
- Experience with Oncology and Neuroscience Therapeutic areas is plus
Additional Information
All your information will be kept confidential according to EEO guidelines.
