Senior SAS Programmer (Onsite)

Stryker•Mahwah, NJ

21h•$100,000 - $166,600•Onsite

About The Position

We are currently seeking a Senior SAS Programmer, Clinical Data Scientist to join our Joint Replacement Division, this is an Onsite position based in Mahwah, New Jersey. What you will do As the Senior SAS Programmer, you will be responsible for implementation of SAS programming in support of clinical trials, including: generation of data tables, listings and reports using SAS; independent validation of statistical programming; assisting in the preparation of statistical analysis plans; contribution to statistical section of clinical trial protocols; generation of real-world evidence from various data sources, and supporting new and ongoing clinical research initiatives. Ensure timely delivery of tables, listing, and summaries requested by users using SAS. Ensure timely delivery of tables, listing, and summaries requested by users using SAS. Develop SAS programs to generate clinical evidence from Real-world data sources (e.g., national registries, hospital registry, commercial datasets, etc.) Periodically review and report on data trends and cleanliness. Do meta-analysis of data across studies to support business needs. Provide programming and statistical analysis support for FDA annual/final submission, post marketing study reports, EU MDR submission, ODEP rating submissions, and publication in professional journals. Support publications by providing reports and statistical analyses to researchers and Investigators. Interface with biostatistician as needed for complex analyses to support publications and reports. Provide input and review statistical analysis plan (e.g., specifications of analysis data sets, pooled data sets, listing, summaries, figures, and tables) for Investigational Device Exemption (IDE) clinical studies, post-marketing studies, and other Real-world clinical trials Creation study reporting using RAVE reporting functions, BO4, and SAS/R Validation study summary report using SAS or R Participate in continuous (breakthrough) improvement activity and process reengineering projects in support of Stryker Orthopaedics’ continuous improvement and global clinical initiatives.

Requirements

Bachelor's Degree in a technical and/or scientific discipline
2+ years of SAS programming experience with 1+ years in a clinical environment
Demonstrated SAS report programming skills and be able to independently handle in-house SAS related requests
Demonstrated working knowledge of statistical methods and principles that are commonly used in clinical trials and be able to assist biostatistician conducting data analysis
Working knowledge of data processing, database design and organization in clinical data environment
Basic knowledge of Food and Drug Administration (FDA) regulations and Standard operation procedures (SOP) as they apply to clinical studies

Nice To Haves

Bachelor’s degree in Biostatistics, Statistics, Computer Science, or related field
M.S. in health/science-related field
Industry experience in medical technology or pharma
2+ years of experience in clinical data management supporting device or pharmaceutical clinical trials

Responsibilities

generation of data tables, listings and reports using SAS
independent validation of statistical programming
assisting in the preparation of statistical analysis plans
contribution to statistical section of clinical trial protocols
generation of real-world evidence from various data sources
supporting new and ongoing clinical research initiatives
Ensure timely delivery of tables, listing, and summaries requested by users using SAS
Develop SAS programs to generate clinical evidence from Real-world data sources (e.g., national registries, hospital registry, commercial datasets, etc.)
Periodically review and report on data trends and cleanliness
Do meta-analysis of data across studies to support business needs
Provide programming and statistical analysis support for FDA annual/final submission, post marketing study reports, EU MDR submission, ODEP rating submissions, and publication in professional journals
Support publications by providing reports and statistical analyses to researchers and Investigators
Interface with biostatistician as needed for complex analyses to support publications and reports
Provide input and review statistical analysis plan (e.g., specifications of analysis data sets, pooled data sets, listing, summaries, figures, and tables) for Investigational Device Exemption (IDE) clinical studies, post-marketing studies, and other Real-world clinical trials
Creation study reporting using RAVE reporting functions, BO4, and SAS/R Validation study summary report using SAS or R
Participate in continuous (breakthrough) improvement activity and process reengineering projects in support of Stryker Orthopaedics’ continuous improvement and global clinical initiatives.