Associate Director, Portfolio Lead, Clinical Data Analytics
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease and the development of best-in-industry data science capabilities is critical to our ambition to be most innovative healthcare company.
Within Integrated Data Analytics & Reporting (IDAR) Clinical and Statistical Programming (C&SP) we are looking for individuals with the motivation to contribute to the growth of the Clinical Data Analytics team, within our Clinical Programming group.
The Clinical Data Analytics group supports the data preparation and report solutions for the clinical data review process including risk-based central monitoring, quality tolerance limits (QTLs), medical review and facilitation of early data insights and decision making as well as support for data management cleaning activities.
This is a leadership position responsible for identifying and driving solutions for analytic support within the clinical data review community across therapeutic areas. Interpret and translate business needs into tangible reporting solutions. Drive the development and implementation of end-to-end analytic requests, reporting processes, metrics and ensure robust and efficient validation process to ensure high quality delivery. Guide Clinical Data Analytics staff in translation of clinical data review needs into technical reporting and visualization solutions.
This position is responsible for high degree of autonomous decisions and recommendations that impact the efficiency, timeliness and quality of deliverables and provide leadership, direction technical and project specific guidance to programming teams.
In Collaboration with senior leadership, this position influences departmental effectiveness acting as a change agent to shape, drive and implement the organizations strategic vision.
- Accountable for planning and execution of Clinical Data Analytics activities on time within budget, and with high quality.
- Proactively evaluates and manages resource demand and allocation to meet current and future business needs ensuring effective utilization of resources and maintenance of functional planning systems.
- Serve as liaison with a variety of end-users and apply holistic approaches to clinical data review and other data related initiatives.
- Interpret and translate a data review business needs into a tangible report/visualization solution.
- Leverage technical expertise and drive strategic use and implementation of new reports/ visualizations and templates.
- Proactively identify data review gaps in current processes and projects and lead/drive discussions to define and implement opportunities
- As required by business needs, lead cross-functional projects which require strong stakeholder management and project management skills
- Management and development of staff per department needs. As a functional manager, they are responsible for the recruitment, onboarding, performance management and development of people and future skills and technical knowledge expertise within their reporting line.
- Ensures effective cross-functional partnership and stakeholder management.
- Bachelor’s degree or higher and/or equivalent in computer science, data science/data engineering, mathematics, or another relevant scientific field. Advanced degree (Master’s, PhD or equivalent) preferred.
- Approximately 10+ years clinical programming data review experience with increasing responsibility OR Masters/MBA in a relevant field with 8+ yrs. relevant experience OR PhD in a relevant field with 6+ yrs. relevant experience.
- Experience in a pharmaceutical/ clinical trial environment preferred.
- In-Depth knowledge of data structures and relevant analytical tools, Spotfire, Tableau, elluminate, Qlik, JReview SAS, R, Python and/or SQL is required.
- Ability to think strategically regarding broad scope analytic solutions, including appropriate infrastructure and technological requirements
Varied Therapeutic Area knowledge.
- Strong analytic and problem-solving skills
Proficient in stakeholder engagement and management
Demonstrated project leadership managing risks, resources, and leading teams to successful outcomes.
Excellent communication, influencing and negotiation skills.
- In depth knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.
- Demonstrated people management skills and experience in staff performance management and people development.
- Experience successfully leading broad scope process improvement/innovation initiatives and/or supporting change management.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States— Other Locations
Europe/Middle East/Africa-Netherlands, North America-Canada, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Poland, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-France, Europe/Middle East/Africa-United Kingdom
Janssen Research & Development, LLC (6084)