The Position

Roche Molecular Systems, Inc. seeks a Principal Statistical Programmer in its Pleasanton, California location.

Develop, modify, and use statistical/computational programs, as well as related statistical and numerical analyses and databases, to analyze and evaluate clinical trials data. Consult with clinical study team members on data analysis and reporting needs. Develop source and analysis datasets from raw data extracted from different electronic data capture (EDC) systems. Develop SAS programs for survival analysis, regression analysis, Kaplan Meier plots, patient profile plots and statistical modelling. Build SAS Macros to retrieve clinical data; schedule jobs using batch scripts; and conduct post processing of raw unstructured Case Report Form (CRF) data and instrument data into Study data tabulation model(SDTM) standards. Assess data accuracy, integrity, and consistency. Responsible for Clinical Data analysis, statistical analysis, generation of tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS to support clinical study reports (CSR) and electronic submissions. Develop extraction programs to create raw datasets, and develop source and analysis datasets from raw data for analysis. Create tables, figures, and listings to support clinical study reports and submission. Provide support for supplemental or exploratory analyses as needed. Create Clinical Data Review Plan (CDRP) reports for the study team. Lead data discrepancy resolution process. Present findings and review output to ensure consistency across programs within study. Analyze and report of real world oncology data to support scientific publications at various industry conferences. Participate in the development and maintenance of data analysis and reporting procedures and standards. Interact with Statisticians and other clinical teams to perform ad-hoc analysis and generate outputs according to the requirements. Lead statistical programmers in designing and implementing statistical solutions. May supervise 0-3 Statistical Programmers. Telecommuting is permitted full-time from anywhere in the US.

Education and experience required: Bachelor's degree in Statistics, Math, Computer Science or Engineering, Information Technology or a related field, and 6 years of progressive, post-baccalaureate experience in a Statistical or Clinical Programmer, SAS Developer or Programmer, or a related role

Special Requirements: Must have 4 years of experience with:

• Application of complex programming techniques using SAS, including Base SAS, SAS/Stat, SAS Macro, SAS Graphics Template Language, and SAS Access for SQL
• Data collection and application of database concepts including data flows in clinical trials
• Implementation of SAS code for statistical analysis and generation of tables, listings, and graphs to create Clinical Study Reports
• Design, development, or validation of statistical software solutions and applying knowledge of statistical concepts
• Developing data insights and dashboards to monitor clinical trials data
• Regulatory submissions to health authorities, including the FDA

The expected salary range for this position based on the primary location for this position of California is $163,282 to $177,700 per year. Actual pay within the range will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 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. Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash)

Worksite: 4300 Hacienda Drive, Pleasanton, California, 94588, United States

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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