• 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

US head of Biostatistics operations.

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

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 monitoring strategy and the tools needed to support central monitoring group. Responsibility quickly increased to the development of more general data driven processes across the organization.• 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• Design and implementation of a novel event based data model for management of clinical trials (patent pending)• Development and acquisition of tools to support centralized data monitoring – including implementation of central statistical monitoring methods on 18 trials• Implementation of graphical patient profiles, safety surveillance reporting, and data reconciliation reporting to support medical monitor and other central review activities. • Statistical consulting including, protocol development, program strategy, representation with regulatory authorities, statistical review, report writing, and complex statistical analysis.• Liaison and maintain rapport with sponsors – negotiation and collaborative problem solving.• Development of patient enrollment modeling and forecast tools applied to more than 1000 clinical trials• Forensic data analysis• Automation of investigator grants payment reconciliation process• Proposal development and sales support

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 relationships with Kendle.

• 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.• Liaison and maintain rapport with sponsors – negotiation and collaborative problem solving.• Development of Standard Operating Procedures and the training of staff.• Interface and coordinate with the biostatistics and other INC Research / INC Research groups on projects and system / process development.• Proposal development and sales support

• 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 • 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• Provide Statistical input for protocol development and write statistical analysis plans.• Liaison and maintain rapport with sponsors – negotiation and collaborative problem solving.• Interface and coordinate with the biostatistics and other INC Research / INC Research groups on projects and system / process development.• Proposal development and sales support

• 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.• Selection and implementation of CDM solution• Oversaw the development and production of all projects.• Wrote analysis plans and statistical reports.• Validated SAS programs and biostatistics databases for multiple projects – as needed.• Managed biostatistics timelines.• Tracked and managed budgets for projects• Aided in the development of protocols by writing the statistical portion of protocols, providing sample size calculations and reviewing protocols.• Proposal development and sales support

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 focusing on health outcomes analyses and healthcare utilization modeling• 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. • Ad hoc programming. • Managed technical staff including direct reports and contracted staff. • Public speaking.

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• Prepared reports to regulatory authorities• Participated in multiple grant funded research projects as lead statistician.