Job Description

• The mission of the Data Intelligence team in the Early Clinical Development (ECD) department is to optimize the support of clinical systems to provide high-quality clinical trial data insights and to offer data science-related consultation to the study teams.
• We leverage cutting-edge data science and operation data management to facilitate the study start-up planning.
• We develop advanced analytical data visualization and conduct predictive analysis to increase the efficiency of clinical data review and clinical operations with the ultimate goal of driving data-driven decision-making throughout the study lifecycle.
• The Risk Based Quality Management (RBQM) Data Analyst sits in the Data Intelligence team and supports ECD study teams by delivering timely and high-quality centralized monitoring tools and analysis, including but not limited to the development and maintenance of reports for study specific Key Risk Indicators (KRIs) and Quality Tolerance Limit parameters (QTLs).
• The RBQM Data Analyst collaborates with RBQM Strategic Leads and other RBQM workgroup members to develop and operationalize the integrated Quality Risk Management Plan (iQRMP) and associated risk mitigation and control strategies, provide processes and tools for oversight of the overall risk and issues management, and offer continuous knowledge sharing and improvement of best practices for study teams to follow.
• The RBQM Data Analyst participates and contributes to cross-business unit RBQM workstreams

• Collaborate closely with RBQM Strategic Leads and other RBQM workgroup members to operationalize the integrated Quality Risk Management Plan (iQRMP), and to manage the identification of critical-to-quality (CtQ) factors, development of risk control strategies, and implementation of risk mitigation activities.
• Collaborate with the global RBQM Center of Excellence (COE) to drive the design and improvement of technology and analysis solutions necessary for RBQM implementation within Roche/Genentech, including in-house systems and potential external technologies.
• Support RBQM Strategic Leads and study teams in selection, set up and maintenance of reports for Key Risk Indicators (KRIs), Quality Tolerance Limit parameters (QTLs), and other applicable assessments and dashboards, ensuring consistency by adopting applicable global standards.
• Lead and perform peer reviews and QC of the ECD specific setup of KRIs and QTLs vs iQRMP and system specifications, as required.
• Support study teams to conduct data surveillance and issue management by defining consistent risk control strategies and acceptable risk limits in collaboration with the RBQM Strategic Leads and other RBQM workgroup members.
• Deliver timely and high-quality risk-based monitoring analytics and support.
• Provide training and knowledge sharing to study teams to promote RBQM analysis solutions and best practices.
• Lead centralized systematic data surveillance across studies in ECD, document surveillance activities, and assess control measure outputs for necessary mitigating actions.
• Analyze data for meaningful trends, trigger mitigating actions, and identify potential issues for knowledge sharing across studies.
• Ensure inspection readiness for the ECD specific RBQM analysis solutions.
• Champion RBQM within the company and collaborate with cross-business unit RBQM SMEs in continuous improvement and development of risk management processes and system as needed.

• Bachelor's degree in Data Science, Statistics, Computer Science, Life Sciences, Public Health, or a related field. Master's degree preferred.
• 5+ years experience in Biotech/Pharmaceutical industry with knowledge of the pharmaceutical/biotech clinical development process
• 7+ years experience in Analytics or Statistics (5+ years of experience with a Masters degree)
• 3+ years of experience in RBQM / RBM processes, including awareness of industry strategy and direction, knowledge and understanding of ICH E8 and ICH E6 requirements
• Strong proven experience using data driven methods to analyze and solve business situations, strong critical thinking and analytical skills and aptitude for data analytics including mathematical and statistical concepts
• Strong systems awareness including good knowledge of data pipelines, models and systems along with strong cross-functional inputs and dependencies contributing to end to end RBQM delivery

• Proficient in data analysis tools (e.g., R, Python, JMP) for manipulating, analyzing large datasets, creating visualizations, and applying statistical methods (hypothesis testing, regression analysis, data modeling) to analyze clinical trial data
• Proficient in data visualization tools (e.g., Tableau, Spotfire)
• Experience and understanding of clinical trial data from various sources (e.g. Veeva, RAVE, IRT, SDTM, clinical devices, etc)

• Strong organizational skills and attention to detail
• Strong interpersonal skills and a consultative mindset, with the ability to develop strong partnerships, highly effective verbal & written communication skills
• Good problem-solving ability, process minded, breaking down complex problems into distinct parts, able to generate refined output from general concept, managing uncertainty, understanding, anticipating interdependencies
• Able to proactively "connect the dots" by asking thought-provoking questions
• Objective when presenting insights and guiding decision-making; demonstrate good presentation skills by pairing sound analytics with storytelling
• Self-accountability, strong sense of responsibility, and integrity
• Able to multi-task and re-prioritize work on short notice, able to lean in and manage through change
• Ambitious, resourceful, works with minimal instruction and oversight
• Highly effective leader and team player

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