Experience

Everest Clinical Research

• Canada
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Director of Biometrics/Statistical Operations

  • 2016 - Present

  Project director and statistics lead/oversight for multiple clients and separate teams nearing BLA submissions. Lead client contact for regulatory statistics communications and setting analysis strategy for regulatory review and integration/standardization of trial data. Supporting business development resulting in new client awards. Consulting with senior management on internal process establishment and strategic planning. Project director and statistics lead/oversight for multiple clients and separate teams nearing BLA submissions. Lead client contact for regulatory statistics communications and setting analysis strategy for regulatory review and integration/standardization of trial data. Supporting business development resulting in new client awards. Consulting with senior management on internal process establishment and strategic planning.



Blue Cross Blue Shield of Michigan

• United States
• Insurance
• 700 & Above Employee

• Director, Health Care Value

  • 2017 - 2018

  Led $10M division of 60 analytics staff supporting value-based reimbursement and provider/facility risk-based contracting, utilization management, and product design and strategy for PPO and HMO products and across commercial and Medicare LOB. Department deliverables included investigative data mining and design of novel observational studies to assess drivers of BOB spend and use of professional, facility, and pharmacy services, program evaluations, clinical metrics development, setting cost/quality/use criteria for provider uplifts, design of interactive cost/use dashboards, HEDIS reporting, data mart maintenance, development of data standards, ingesting non-claims based data, automation of routine reporting, and ad hoc analysis delivery across the enterprise. Chair of research committee, representative on internal data and analytic governance committees, and advisory board member on external population health steering committees. Managed division through significant organizational change including full redesign, improved customer service, vendor assessments, process documentation, and agile roll-out.



UnitedHealth Group

• Hospitals and Health Care
• 700 & Above Employee

• Director/Senior Director, OptumInsight

  • 2011 - 2016

  Directed Medicare Supplement health services research and program evaluation for one of UHG’s largest clients. Contributed to departmental research agenda and member of leadership team. Directed programmers and medical writers in support of research projects. Conducted literature reviews and consulting with clinical staff to design and interpret studies. Authored analysis plans and manuscripts; presented findings to internal and external audiences. Performed exploratory analysis of medical and pharmacy claims, member surveys, and quality metrics. - Global head of data management, statistical programming, statistics, and medical writing services for phase IIIb/IV clinical trials, observational studies, registries, direct-to-patient surveys, and health economic studies. Built Global Data Management group from scratch to size 15, yielding annual revenues >$1.5M. Served as expert clinical biostatistics consultant and grooming over 15 statisticians and medical writers in support of clinical research. Support of business development through bid defenses, audits, pricing, marketing, and client steering committees. Established IT platforms as business owner overseeing inception and evolution of in-house EDC application, qualification and selection of third party vendors, as well as in-house clinical data repository. Drove process establishment, refinement, and training of over 30 integrated Biometrics SOPs. Led change management initiatives through acquisition.



Lundbeck

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Director, US Biometrics

  • 2010 - 2011

  Provided strategic, scientific and managerial leadership to a team of 20 biostatisticians, clinical data managers, and biometric programmers supporting phase I-IV clinical development for neuroscience products. Responsible for vendor management, resourcing, $2.5M budget, and staff coaching/development. Participated in and ensuring completeness of the regulatory submission process, including INDs, CTAs, CTDs and NDAs. Assumed a leadership role in process improvement, training, and standards development. Participated in the Global Biometric Management group by providing strategic leadership to identify potential integration issues, developing creative approaches to surmount them, and driving implementation of solutions.



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Principal Research Scientist/Group Leader, Global Statistical Sciences & Advanced Analytics

  • 2006 - 2010

  Supervised team of 13 M.S./Ph.D. local and remote statisticians/programmers, evaluating vendor performance, and performing resource planning/budgeting. Lead global submission activities, global regulatory responses, labeling, right-to-operate documents, customer response, and phase III/IV statistical support for Cialis®, including marketing alliance. Served as senior consulting statistician leading pediatric and hematology indications for Alimta® and other late phase oncology compounds. Forged relationship with external research organizations, created shared learning forums, and performed senior scientific disclosure reviews. Represented department on global Six Sigma and SOP authoring projects.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Director, Clinical Statistics

  • 1997 - 2006

  Served as a clinical biostatistician twice promoted to increased levels of responsibility for phase I-III compounds in oncology, anti-infectives (Zithromax®) respiratory, and inflammation. Led statistical activities for a phase III alliance program by providing input to overall project strategy, directing junior and senior level statisticians to support NDA/MAA and study related work, formulating regulatory responses, interfacing with and influencing partner company statistical leads, managing CRO activities and budgets, providing technical input for legal contract review, conducting advanced statistical programming, presenting statistical concepts and results to internal and external audiences. Developed position papers dealing with and conducting collaborative research for statistical issues within the pharmaceutical industry. Managed student fellows and interns.