1 Clinical SAS Programmer Job in Lawrence, MA
Katalyst Healthcares & Life Sciences is Hiring a Clinical SAS Programmer Near Lawrence, MA
- 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 related to SDTM and submission standards.
- Minimum of 4years 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).
- 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 (Review, Spotfire, Tableau) is a plus.
- Experience with Oncology and Neuroscience Therapeutic areas is a plus.
Job Summary
Contractor
$80k-102k (estimate)
05/31/2024
07/22/2024
katalysthls.com
South Plainfield, NJ
<25
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The job skills required for Clinical SAS Programmer include Programming, SAS, Biotechnology, Oncology, Quality Control, Programming Language, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical SAS Programmer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical SAS Programmer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical SAS Programmer positions, which can be used as a reference in future career path planning. As a Clinical SAS Programmer, it can be promoted into senior positions as a Business Systems Analyst II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical SAS Programmer. You can explore the career advancement for a Clinical SAS Programmer below and select your interested title to get hiring information.
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