88-50100108 Senior Clinical Programmer

Roche•Pleasanton, CA

1d•Remote

About The Position

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position Roche Molecular Systems, Inc. seeks a Senior Clinical Programmer at its Pleasanton, California location. Duties: Develop software solutions for statistical modeling and analysis of clinical data for both registration and non-registrational clinical studies for medical diagnostics and serve as lead programmer. Analyze user requirements and implement, update, and enhance software solutions to deliver accurate and complete data/reports to support regulatory submissions in the area. Apply principles and techniques of Information technology in conjunction with application quantitative analysis to contribute to developing, validating, and documenting software applications and programs to meet clinical study needs. Develop and modify SAS programs to analyze and evaluate clinical data along with assessing data accuracy and consistency. Develop all extraction programs to create raw datasets related to the study. Create data specifications to generate source and analysis datasets as defined in study requirements. Build source and analysis datasets from raw data to support clinical trial data analysis. Review and provide input for CRFs (case report form), edit check specifications, SAP (statistical analysis plan), and TLF (table listings figures) mock-ups. Provide software support to supplemental or exploratory analyses for regulatory agencies or any other ad-hoc requests. Review, maintain, and provide approval for validation plans and associated documentation, ensuring alignment with standard operating procedures and regulatory requirements throughout the study data validation lifecycle. Develop standardized procedures to perform analysis across life cycles and projects. Ensure regulatory requirements, including FDA. Telecommuting allowed up to 5 days a week from anywhere within the US. May supervise 0-3 Statistical Programmers.

Requirements

Bachelor’s degree in Computer Science, Electronics Engineering, Information Technology, Data Science, Statistics, or a related quantitative field and 5 years of post-baccalaureate and progressive experience as a Statistical Programmer, SAS Programmer, Clinical Programmer, or closely related position in the medical diagnostics, medical device, or pharmaceutical industry
Statistical software design, including development and validation of statistical programming tools and analysis datasets related to clinical trials.
Advanced programming using Base SAS, SAS Macro, SAS/Stat, and SAS SQL for generating clinical study outputs including Tables, Listings, and Figures (TLFs), as well as automation of clinical reporting processes.
Oracle, SQL Server, and SAS/ACCESS interfaces, including writing of complex queries, data extraction and transformation, and integrating databases with SAS for clinical programming tasks

Responsibilities

Develop software solutions for statistical modeling and analysis of clinical data for both registration and non-registrational clinical studies for medical diagnostics and serve as lead programmer.
Analyze user requirements and implement, update, and enhance software solutions to deliver accurate and complete data/reports to support regulatory submissions in the area.
Apply principles and techniques of Information technology in conjunction with application quantitative analysis to contribute to developing, validating, and documenting software applications and programs to meet clinical study needs.
Develop and modify SAS programs to analyze and evaluate clinical data along with assessing data accuracy and consistency.
Develop all extraction programs to create raw datasets related to the study.
Create data specifications to generate source and analysis datasets as defined in study requirements.
Build source and analysis datasets from raw data to support clinical trial data analysis.
Review and provide input for CRFs (case report form), edit check specifications, SAP (statistical analysis plan), and TLF (table listings figures) mock-ups.
Provide software support to supplemental or exploratory analyses for regulatory agencies or any other ad-hoc requests.
Review, maintain, and provide approval for validation plans and associated documentation, ensuring alignment with standard operating procedures and regulatory requirements throughout the study data validation lifecycle.
Develop standardized procedures to perform analysis across life cycles and projects.
Ensure regulatory requirements, including FDA.