Sr. SAS Programmer
Sr. SAS Programmer
Posted on :
07-06-2025
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1 Vacancy
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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.
- Bachelors or masters 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
Employment Type
Full Time
Key Skills
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