Roche · 3 months ago
88-50100109 Senior Data Scientist (Quality Excellence Lead)
South San Francisco
Full-time
Onsite
Mid, Senior Level
$172K/yr - $221K/yr
1+ years expGenentech, Inc. is seeking a Senior Data Scientist (Quality Excellence Lead) at its South San Francisco, CA location. The role involves reviewing and analyzing clinical study data to ensure quality compliance, utilizing advanced analytics, and collaborating with the Quality team to present findings and improvements.
BiotechnologyHealth CareHealth DiagnosticsOncologyPharmaceuticalPrecision Medicine
Responsibilities
Review and analyze inferences made on clinical study data by the Quality Audit team and present statistics based opinions to check for clinical quality compliance using R, Python and Amazon Web Services (AWS) packages
Provide analytical expertise in clinical data quality, improvement opportunities, and understanding of variations in the clinical study data and quality metrics
Use descriptive and advanced analytics such as machine learning, statistical models and natural language processing techniques to identify data points of interest and trends in clinical study data and conducts a risk assessment to the quality impact factors
Assess clinical data before study audits and health authority inspections (Food and Drug Administration (FDA)/EMEA) to mitigate potential risks
Use statistical analysis to identify improvements and opportunities for clinical quality gap closure and determine the methods of analytics that needs to be used after carefully evaluating the clinical data and client requirement
Identify appropriate methodologies by writing code to statistically analyze output to provide subject matter expertise on clinical quality metrics development to analyze and report on quality measures
Identify raw data in clinical systems such as electronic case report forms (eCRFs), financial disclosure forms etc. and conducts data wrangling to check for data consistency and identifies inaccuracies within the data using Python, R and AWS packages and visualizations using Tableau
Conduct analysis to assign weights to features within large clinical datasets to use for prospective predictive analytics and deep learning projects
Work with the Quality team to iteratively validate data using R, Python, Machine Learning, Artificial Intelligence, Natural Language Processing, techniques and develops visualizations using Tableau to present results to team
Work with auditors to present case studies of the use of analytics in clinical trial – quality assurance at international conferences like DIA etc
Review and analyze data from multiple internal/external sources to create dashboards, drill down reports and key quality performance indicators
Qualification
Required
Master's degree in Data Analytics, Data Science, or related field
1 year of experience as a data scientist or analyst, clinical data manager or analyst, or related role
1 year of experience with Clinical study data standards including Clinical Data Interchange Standards Consortium (CDISC) and Standard Data Tabulations Model (SDTM)
1 year of experience with Good Clinical Practices (GCP) Clinical Trial Process and documentation, Investigator Brochures, Protocols, Informed Consent Forms
1 year of experience with collection and maintenance clinical data systems such as electronic data captures systems, electronic trial master systems and clinical trial management systems
1 year of experience with Quality and Good Clinical Practices (GCP) relating to Clinical Trial Process and associated documentation i.e., Investigator Brochures, Protocols, Informed Consent Forms
1 year of clinical study quality auditing experience
6 months of experience applying Statistical Models to clinical study data
Benefits
A discretionary annual bonus may be available based on individual and Company performance.
Company
Roche
Roche is a pharmaceutical and diagnostics company that offers medicines and diagnostic tests for various medical conditions and diseases.
10001+ employees
H1B Sponsorship
Roche has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (9)
2023 (6)
2022 (2)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$7.79BKey Investors
SoftBankSCALE AINovartis
2021-08-04Post Ipo Equity· $5B
2020-12-07IPO
2020-05-06Post Ipo Equity· $0.5M
Leadership Team
Alan Hippe
Member of the Executive Board - Group CFO
Christine Bakan
Global Head and VP of Software and Bioinformatics, Next Generation Sequencing
Recent News
Labiotech UG
2026-01-17
2026-01-16
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