Data Analyst (Biotechnology)

The role of the Data Analyst will 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. You will leverage cutting-edge data science and operation data management to facilitate the study start up planning. This is a 12-month contract onsite position.

Responsibilities:

• Collaborate closely with Strategic Leads and other workgroup members to operationalize the integrated Quality Risk Management Plan, and to manage the identification of critical-to-quality (CtQ) factors, development of risk control strategies, and implementation of risk mitigation activities.
• Drive the design and improvement of technology and analysis solutions necessary for implementation, including in-house systems and potential external technologies.
• Support 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 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 Strategic Leads and other workgroup members.
• Deliver timely and high-quality risk-based monitoring analytics and support.
• Provide training and knowledge sharing to study teams to promote analysis solutions and best practices.
• Lead centralized systematic data surveillance across studies, 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 analysis solutions.

Qualifications

• 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 Risk Based Quality Management 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).

Salary

• $86,070-$109,324

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance – PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.