88-50100571 Analytical Data Scientist

Roche • South San Francisco, CA

2d • $147,192 - $197,500 • Hybrid

About The Position

Genentech, Inc. seeks an Analytical Data Scientist at its South San Francisco, CA location. Duties: As a key contributor to the clinical study team, responsible for transforming statistical analysis plans into high-quality, traceable programming deliverables using advanced statistical and mathematical concepts. Support development and validation of datasets and statistical outputs for clinical studies, including Study Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and tables, listings, and figures (TLFs), by following established internal standards and using validated programming tools. Create and validate datasets in accordance with Study Data Tabulation Model and Analysis Data Model standards, ensuring compliance with regulatory requirements and company standards. Support regulatory submissions and play a critical role in generating data insights through platforms such as the Insight Engine, enabling real-time exploration and interpretation of diverse clinical and exploratory data. Contribute to program creation statistical analysis system language and analysis of a broader range of data types, including biomarker and exploratory datasets, to support scientific discovery beyond regulatory submissions. Construct predictive models, algorithms, and probability engines to support data analysis and product functions, and support exploratory analyses across disease areas to assist in developing visualizations or dashboards for data exploration using interactive applications and data insights platforms. Collaborate with senior programmers to understand study requirements and execute assigned programming tasks; partner with biostatisticians, clinicians, medical services, and clinical data management staff in establishing standards for clinical data collection, management, and reporting of data. Participate in documentation and quality control activities, contributing to reproducible and accurate outputs and ensuring alignment with programming specifications; responsible for data integration used for clinical summaries and the creation and quality control of statistical submission components to regulatory agencies. Apply expertise in manipulating and analyzing various data types related to clinical trials such as patient characteristics, lab values, and imaging (may also include digital health, genomic data, and biomarkers). Implement data management plans designed to meet project and protocol deadlines. Recognize inconsistencies and initiate resolution of data problems. Work under general supervision and apply independent judgment to interpret guidance, prioritize responsibilities, and make decisions in situations that require contextual understanding. Work cross-functionally with stakeholders, including biostatistics, data management, and clinical operations, to define analysis plan, timelines and deliverables. May telecommute up to 2 days per week.

Requirements

• Master’s degree, or foreign equivalent, in mathematics, statistics, biological sciences, computer science, data science, or related field and one (1) year of experience as a Biostatistician, Data Scientist, Statistical Programmer, Analyst or related position
• Pharmaceutical and drug development industry knowledge
• Real-world big data analysis, statistical computing and statistical analysis skills including Bayesian analysis and survival analysis
• Knowledge of CDISC (Clinical Data Interchange Standards Consortium) data standard
• Version control and Command Line Interface (CLI) commands such as git, gitlab, or github
• R programming including R shiny, R markdown, and Tidyverse
• SAS Programming
• Python Programming
• Machine Learning and Natural Language Processing
• Business Intelligence (BI) data visualization platforms
• Tableu or PowerBI
• SQL (Structured Query Language) and ETL (Extract-Transform-Load) pipeline

Responsibilities

• Transforming statistical analysis plans into high-quality, traceable programming deliverables using advanced statistical and mathematical concepts.
• Support development and validation of datasets and statistical outputs for clinical studies, including Study Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM) datasets, and tables, listings, and figures (TLFs), by following established internal standards and using validated programming tools.
• Create and validate datasets in accordance with Study Data Tabulation Model and Analysis Data Model standards, ensuring compliance with regulatory requirements and company standards.
• Support regulatory submissions and play a critical role in generating data insights through platforms such as the Insight Engine, enabling real-time exploration and interpretation of diverse clinical and exploratory data.
• Contribute to program creation statistical analysis system language and analysis of a broader range of data types, including biomarker and exploratory datasets, to support scientific discovery beyond regulatory submissions.
• Construct predictive models, algorithms, and probability engines to support data analysis and product functions.
• Support exploratory analyses across disease areas to assist in developing visualizations or dashboards for data exploration using interactive applications and data insights platforms.
• Collaborate with senior programmers to understand study requirements and execute assigned programming tasks.
• Partner with biostatisticians, clinicians, medical services, and clinical data management staff in establishing standards for clinical data collection, management, and reporting of data.
• Participate in documentation and quality control activities, contributing to reproducible and accurate outputs and ensuring alignment with programming specifications.
• Responsible for data integration used for clinical summaries and the creation and quality control of statistical submission components to regulatory agencies.
• Apply expertise in manipulating and analyzing various data types related to clinical trials such as patient characteristics, lab values, and imaging (may also include digital health, genomic data, and biomarkers).
• Implement data management plans designed to meet project and protocol deadlines.
• Recognize inconsistencies and initiate resolution of data problems.
• Work under general supervision and apply independent judgment to interpret guidance, prioritize responsibilities, and make decisions in situations that require contextual understanding.
• Work cross-functionally with stakeholders, including biostatistics, data management, and clinical operations, to define analysis plan, timelines and deliverables.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• Benefits detailed at the link provided below. Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level