John Whitaker Email & Phone Number

Apex, NC, US

Covington, KY, US

Research Triangle Park, NC, US

• Provide strategic leadership and operational guidance to the Biostatistics, Statistical Programming, Data Management, and Medical Writing departments
• Establish a global delivery strategy and grow the operations implementing and performing Biostatistics, Statistical Programming, Data Management, and Medical Writing services globally
• Oversee departmental services delivery
• Provide functional expertise internally and externally
• Oversee the development and implementation of SOPs and other procedural documents

Morrisville, North Carolina, US

US head of Biostatistics operations.

• Regulatory support
• Data Analysis and Statistical Programming
• Protocol Design
• Data Quality Review

Raleigh, North Carolina, US

• Implemented a new group designed to provide cross-functional consulting to the company and serve as an incubator for new process and technology development. Focus initially was on the development of a risk-based.
• Development, implementation, and continued enhancement of a Risk-Based Monitoring strategy for INC – applied to 52 trials
• Business process improvement – implementation of an end-to-end software solution including integrated CTMS, CDM, and financial systems
• Pioneered the use of claims, lab and other real world data for site identification, feasibility assessment, and protocol development
• Selection and global implementation of project management software
• Design and implementation of management reporting systems for project management and reporting

Raleigh, North Carolina, US

This position is responsible for global operations for statistical analysis and programming. Current operations are in offices in the United States, Scotland, England, Mexico, China, and Germany. Provides consulting for program development, regulatory submission, and statistical analysis. Works with sponsor companies to develops strategic partnering.

Raleigh, North Carolina, US

• Grew the Biostatistics and programming group from 7 to more than 60 staff and sales from ~$2m annually to more than ~$19m annually.
• Overall operational responsibility for the Biostatistics group in offices across US, Europe, and India.
• Statistical consulting including, protocol development, program strategy, representation with regulatory authorities (FDA and MHRA), statistical review, report writing, and complex statistical analysis.
• Submission Support – End of Phase II, Pre-NDA, ISS, ISE, and general submission support
• Analysis and interpretation of clinical trials data, including production of ICH compliant tables, listing, and figures.
• Provide Statistical input for protocol development and write statistical analysis plans.

Raleigh, North Carolina, US

• Overall operational responsibility for the Biostatistics group in offices across US, Europe, and India.
• Harmonization of processes across locations
• Start-up of India based programming team
• Grew the Biostatistics and programming group from 7 to more than 60 staff and sales from ~$2m annually to more than ~$19m annually
• Active statistical lead on projects providing analysis and interpretation of clinical trials data, including production of ICH compliant tables, listing, and figures.
• Staff mentoring and development

Wilmington, NC, US

• Responsible for the resource planning and personnel management of the statistical and programming teams.
• Responsible for managing and utilizing human resources for the department – including personnel recruitment, promotion, and termination; allocation/coordination of work assignments; and conflict resolution.
• Assist in implementing policies regarding performance planning and evaluation for the department.
• Participated in divisional decision-making, bid preparation and marketing activities.
• Reviewed documents related to project activities – including senior technical review for Biostatistics and Programming.
• Responsible for liaison with other departments within the company and for clients.

• Senior technical role responsible for statistical analysis, reporting and for overall corporate technical strategy. Lead statistical analysis of large research projects including observational longitudinal studies.
• Real World Evidence - Data mining of large administrative data bases (medical claims, hospital reporting, lab data)
• Design and development of site level quality monitoring software using MDS data
• Designed and implemented of overall technology strategy.
• Capital budgeting and purchasing.
• Responsible for quantitative and fiscal analysis, included product pricing, business plan development, and ad hoc analysis to aid executive decision-making.

Menands, New York, US

• HIV / AIDS, Mental Health, and Drug Abuse specific research. Conducted statistical analysis for research projects and on an ad hoc basis to support executive decision making.
• Real World Evidence – analysis of health outcomes, quality of care, healthcare utilization, and economic models using medical claims, prescription, lab, and other administrative data basis.
• Lead activities on multiple research grants
• Advanced statistical methods; including, longitudinal data analysis, survival, and mixed models
• SAS Programming
• Data warehousing

Ph.D., Administrative Engineering Systems, Advanced Statistics

Ms, Operations Research And Statistics

Bs, Finance

Education record