Bristol-Myers Squibb Company

Director, Clinical Data Reporting and Analytics

Princeton, NJ, US
Jun 03, 2018
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time
The Director, Clinical Data Reporting and Analytics is a leadership role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Executive Director, Global Data Management and Centralized Monitoring within Global Clinical Operations (GCO).

Specifically, the Director, Clinical Data Reporting and Analytics is accountable for:

Providing operational leadership of the clinical data reporting and analytics function enabling the presentation of clinical trial datasets, data reports, listings, and visualizations to various stakeholder groups for data review, patient safety oversight, protocol deviation and data trend detection, internal decision making, and statistical analysis.

Ensuring high quality and timely delivery of clinical data reports, listings, and analytics to BMS stakeholders that support effective clinical trial data review. Providing expert consult on the best fit technology (e.g. SpotFire, JReview, SAS/SQL, etc.) and representation of data in order to meet the stakeholder objectives.

Collaboration with clinical data management and other BMS stakeholders to ensure clear documentation of clinical data reporting and analytics requirements, including user acceptance testing to ensure high quality deliverables and inspection readiness at all times.

Supporting quality management activities at a trial level and across trials in collaboration with the centralized monitoring function and other key BMS stakeholders by providing robust reports/analytics used to detect trends, protocol deviations, and any risks to clinical trial data quality.

Providing support to the creation of Standardised MedDRA Queries (SMQs) and Standardized Drug Groupings (SDGs) in partnership with the medical coding function.

Oversight of the clinical data reporting strategies across trials to enable the effective reporting of patient data supporting regulatory filings, publications and other high-profile business activities.

Ensuring effective quality oversight and management of external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing clinical data reporting and analytics services on behalf of BMS.

Understanding industry evolution to provide insight in the development and application of smart systems and optimal approaches to support the monitoring, cleaning, and reporting of data to simplify and enhance user experience or lead to efficiencies in execution.

Focusing on continuous improvement, defining and implementing the changes required to create an industry-leading clinical data capability, including analytics, ad-hoc analysis and end-to-end data standards.

Leading a multi-national team of clinical trial, data, and technology professionals that contribute significantly to BMS portfolio of clinical trials. Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential. Empowers and holds to high quality performance and delivery of the business.

Ensuring adaptive management of a global team through the effective deployment of resources and streamlined processes, ensuring productivity targets, validity and quality of the data gathered in support of the evolving portfolio of BMS products.

Representing the Company in interactions with key external partners as part of any committee or industry group relating to clinical data reporting, analytics, and technology.

Developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

Engaging and energizing employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities.

Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.

Experience and expertise required:

Bachelor's degree required with an advanced degree preferred. At least 8 years of relevant industry experience, with experience of managing staff in a global setting.

Significant global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices. Immuno-Oncology therapeutic experience is highly desirable.

Expert knowledge of industry leading reporting and analytics tools (e.g. SpotFire, Tableau, SAS/SQL, JReview, etc.) and well versed in industry trends and emerging industry dynamics supporting clinical data reporting.

A very good understanding of database and dictionary structures (e.g. MedDRA, WHODrug).

Strong technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.

A strong understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena.

Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.

Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.)

Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact.

Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.