Senior Data Scientist (Quality Excellence Lead)

The Position

Genentech, Inc. seeks a Senior Data Scientist (Quality Excellence Lead) at its South San Francisco, CA location.

Duties : Description : 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.

Education / Experience Requirement : Master's degree in Data Analytics, Data Science, or related field, and 1 year of experience as a data scientist or analyst, clinical data manager or analyst, or related role.

Specialized Experience : Position requires 1 year of experience with the following :

• Clinical study data standards including Clinical Data Interchange Standards Consortium (CDISC) and Standard Data Tabulations Model (SDTM);
• Good Clinical Practices (GCP) Clinical Trial Process and documentation, Investigator Brochures, Protocols, Informed Consent Forms;
• Collection and maintenance clinical data systems such as electronic data captures systems, electronic trial master systems and clinical trial management systems;
• Quality and Good Clinical Practices (GCP) relating to Clinical Trial Process and associated documentation i.e., Investigator Brochures, Protocols, Informed Consent Forms;
• Clinical study quality auditing experience.

Position requires 6 months of Applying Statistical Models to clinical study data.

Worksite : 1 DNA Way South San Francisco CA, 94080

The expected annual salary range for this position based on the primary location for this position of South San Francisco, California is $172,008.00 to $221,000 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 Apply (insert link)(Job ID)

Genentech 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 company's 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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