Clinical SAS Programmer
2 weeks ago
- Lead and participate in the development and validation of high quality CDISC datasets based on the implementation guides and consultations with sponsors, project leads, systems analysts, other programmers, and end users.
- Use your expertise in data standards and regulatory requirements to lead discussions with clients about appropriate approaches to database design.
- Use study protocol, CRF, Data Transfer Agreements from vendors, data sources, CDISC CT, TAUGS, and CDISC implementation guides to independently author SDTM specifications from scratch; use Pinnacle 21 to run data conformance and create define.xml for SDTM and ADaM submissions .
- ct as the CDISC subject matter expert .
- Convert designs and specifications into computer code and analyze code to find causes of errors and revise programs
- BA/BS in computer science, statistics, computer science, or public health with at least 5 years performing statistical programming in the SAS language within the CRO/Pharmaceutical industry.
- Extensive experience and understanding in.
- SDTM model including transforming raw data files while adhering to CDISC standards from end to end (raw data to eSub); advanced understanding of SDTM model and experience with ; both specification, programming, and conformance of SDTM CDISC; strong CDISC skills with an emphasis on SDTM End to End submissions experience.
- DaM model and experience with both specification, programming, and conformance of ADaM CDISC is a plus.
- SAS/Base knowledge with an emphasis on data step programming; competency modifying pre-existing SAS code, as well as writing SAS code from specs.
- Clinical trials including knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Data/submission conformance tools (such as P21), creation of define.xml, SDSP, and study data reviewer's guides.
- Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and companies.
-
Principal Statistical Programmer
2 weeks ago
Bridgewater, United States Connect Life Sciences Full timeActs as the lead programmer or project lead on studies of significant complexity, working directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets.Assumes leadership responsibility as a contributing member of a multidisciplinary...
-
Principal Statistical Programmer
4 weeks ago
Bridgewater, United States Connect Life Sciences Full timeActs as the lead programmer or project lead on studies of significant complexity, working directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets.Assumes leadership responsibility as a contributing member of a multidisciplinary...
-
Occupational Health Nurse
2 days ago
Bridgewater, MA, United States Michelin Full timeOccupational Health Nurse * - - - - - - - - - - - Discover More than a Career with Michelin Occupational Health Nurse (Contract Position) Bridgewater, Nova Scotia Since 1889, Michelin has innovated to enhance the mobility of people and goods. Today, we are setting the benchmark across every tire and travel-related services market, while leading a global...
-
OCCUPATIONAL HEALTH NURSE
1 week ago
Bridgewater, MA 02324, USA, United States Michelin Full timeOccupational Health Nurse* - - - - - - - - - - -Discover More than a Career with MichelinOccupational Health Nurse (Contract Position)Bridgewater, Nova ScotiaSince 1889, Michelin has innovated to enhance the mobility of people and goods. Today, we are setting the benchmark across every tire and travel-related services market, while leading a global strategy...