- 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.
QUALIFICATIONS & EDUCATION - 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
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Sr SAS Programmer - Woodcliff Lake, United States - Advanced Clinical
Description
OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a remote Senior SAS Programmer. The Sr. SAS Programmer will be responsible for leveraging their extensive experience and expertise to lead the development, implementation, and validation of SDTM (Study Data Tabulation Model) datasets for clinical trials. They will collaborate closely with cross-functional teams, including biostatisticians, data managers, and clinical research associates, to ensure the accuracy, completeness, and compliance of clinical trial data. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
