88- Senior Clinical Programmer

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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.

Education and experience required: Bachelors 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

Alternative education and experience required: Masters 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.

Special Requirements: Full term of experience (5 years with a qualifying Bachelors and 3 years with a qualifying Masters) must include:

1. Statistical software design including development and validation of statistical programming tools and analysis datasets related to clinical trials.

2. 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.

3. 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

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

Worksite: 4300 Hacienda Drive Pleasanton CA 94588

The expected annual salary range for this position based on the primary location for this position of Pleasanton California is $139901 to $149600 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 ( we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.

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