[Remote] 88-50100108 Senior Clinical Programmer

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Note: The job is a remote job and is open to candidates in USA. Roche is a global healthcare company dedicated to advancing science and ensuring access to healthcare. The Senior Clinical Programmer will develop software solutions for statistical modeling and analysis of clinical data, contributing to regulatory submissions and supporting clinical trial data analysis.


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
  • Telecommuting allowed up to 5 days a week from anywhere within the US
  • May supervise 0-3 Statistical Programmers

Skills

  • 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
  • Master's degree in Computer Science, Electronics Engineering, Information Technology, Data Science, Statistics, or a related quantitative field, and 3 years of professional experience as a Statistical Programmer, SAS Programmer, Clinical Programmer, or closely related position in the medical diagnostics/device or pharmaceutical domains
  • 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

Benefits

  • A discretionary annual bonus may be available based on individual and Company performance.
  • This position also qualifies for the benefits detailed at the link provided below.

Company Overview

  • Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases. It was founded in 1896, and is headquartered in Basel, Basel-Stadt, CHE, with a workforce of 10001+ employees. Its website is http://www.roche.com.

    • Company H1B Sponsorship

  • Roche has a track record of offering H1B sponsorships, with 12 in 2025, 9 in 2024, 6 in 2023, 2 in 2022, 2 in 2021. Please note that this does not guarantee sponsorship for this specific role.

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