Senior Clinical Data Scientist Lead

Do you want to watch clinical development change, or do you want to be the one to shape it?

Because we’re hoping you’re here for the latter.

Who are we?

We Are PRA.

We are 20,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.

• Serves as the primary contact for internal and external team members regarding clinical data management data review activities
  and leads these review activities to ensure the delivery of data fit for analysis.
• Provides input into clinical system development activities, to ensure systems support the data review needs of the study, focusing
  on critical data and processes, and identified risks.
• Ensures clinical data management review requirements are put into production per the study’s protocol risk evaluation and
  integrated data review plan (IDRP), and that ongoing data review activities are compliant with study plan requirements.
• Contributes to the development and maintenance of study plans documents specifying data review strategy and applicable
  procedures on assigned protocols/projects, including but not limited to data management plan.
• Develops and oversees timeliness of clinical data management activities during the life cycle of studies as it relates to data review
  and data delivery milestones.
• Centrally reviews clinical data at aggregate level, using analytic reporting tool(s) to support the identification of risks and data
  patterns/trends. Mitigates risks by using signal detection and quality indicators.
• Communicates and triages issues to appropriate roles for follow-up and action to address root cause.
• Proactively identifies out-of-scope clinical data management activities to the study project managers to be implemented in required
  change orders.
• Leads and hosts the data monitoring meetings, communicating issues to the internal and external stakeholders in a meaningful
  way such as summarizing the data and representing the information visually.
• Leads clinical data management activities on more complex projects with diverse scope.
• Leads clinical data management activities on projects with diverse scope.
• Accountable for creating and maintaining clinical data management timelines, to oversee and achieve high quality interim and final contractual deliverables for complex projects.
• Using high level knowledge of the protocol, identifies critical data and processes from protocol review, and supports protocol risk evaluation process.
• Works with assigned project teams to communicate, address and resolve data-related issues and recommends potential solutions; escalates issues
  which potentially impact patient safety or study analysis.
• Trains and mentors new and less experienced team members.
• Participates in sponsor and/or third party audits as required.
• Develops tools/analytics used to monitor compliance and identify trends.
• Supports business development as needed.
• Develops and maintains data review study documentation as appropriate to facilitate data validation and analytics.
• Performs analytic reviews as defined in the scope of work and functional plan, focusing on errors that matter or have a meaningful impact on the safety of the subject or interpretations of the final analysis. Identifies root cause to systematically resolve data issues.
• Sets expectations and ensures consistency in data review approach and compliance and identifying trends.

• Bachelor’s degree in quantitative, scientific or health related field required.
• 5 years of relevant experience required.
• Basic knowledge and/or understanding of analytic open source and/or enterprise level extract, transfer, load (ETL) and analytic tools and practices
• Aptitude for understanding analytic modeling methods such as regression, classification and clustering
• Basic programming skills in applicable systems, e.g., R, SQL, Python, SAS
• Skill to efficiently navigate through large volumes of data, to interpret data problems, and to apply technical solutions
• Ability to analyze a data issue and design paths to effective potential solutions, understanding the impact of suggested solutions and to help the
  project team make better decisions
• Strong knowledge of the drug development process including risk-based monitoring principles, clinical and biometrics procedures, workflows, and
  software systems
• Strong skills in interpreting protocols and identifying risks and appropriate mitigation strategies for clinical studies
• Skill in aggregate data review and interpretation using visualization/ analysis software, e.g., JReview, Tableau, SAS.
• Strong leadership and project management skills
• Strong written and verbal communication and presentation skills
• Ability to work collaboratively and effectively in a crossfunctional and culturally diverse team
• Strong ability to proactively, represent clinical data management internally and externally for all study related items and find pragmatic solutions in
  compliance with regulatory requirements and policies.
• To qualify for a position located in the United States, U.S. applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.