Dan Godoy, Pmp Email & Phone Number

San Diego, CA, US

Harwell, Oxfordshire, GB

Responsible for the Biostatistics & Data Management functions - providing leadership and developing a best-in-class internal biometrics function, growing our Statistics and Data Management teams across the UK and USA. Managing biometrics and IRT vendors, including contract negotiation, budget management, and quality oversight. Conducting statistical.

Austin, Texas, US

• Responsible for the Biostatistics, Statistical Programming, Data Management and Medical Writing functions - providing leadership to the Biometrics function, developing the team and providing opportunities for growth.
• Provided Leadership & influencing shape and scope of Biometrics & Clinical Operations teams to implement new hybrid Operating Model
• Redesigned Biometrics team, incorporating multi-level leadership structure to optimize FTE & contractor Headcount, and implementing FSP model
• Provided leadership to Biometrics team and Medical Organization to prepare for EMA & FDA Inspections
• Provided leadership to balance & prepare budget for new fiscal year, redesigned Preferred Providers List based on portfolio changes

Tokyo, JP

• Provided vision, strategic leadership, infrastructure and operational direction for Global CDM function. Forecasted and managed budget, timelines, and resource needs to meet corporate objectives & requirements..
• Provided strong contribution & benchmarking data to validate Takeda’s decision to implement an R&D Hybrid Operating Model (FutureFit)
• Provided Leadership & influencing shape and scope of new R&D teams; leading CDM organization through major transformation
• Reshaped Clinical Data Standards & Standards governance as foundational component for new R&D Hybrid Operating Model (FutureFit)
• Redesigned CDM team, incorporating multi-level leadership structure to handle additional Headcount, and implementing FSP model.

Cambridge, Cambridgeshire, GB

• Responsible for developing/maintaining Biometrics Processes through Data Standards and Governance Models across R&D for small/large molecules throughout their life cycle. Drive internal collaborations to deliver.
• Delivered Data Standards Framework for Clinical, including MedImmune Biologics Governance Team and Joint large-small molecules MedImmune-AZ Governance to ensure seamless transfer of Biologics early-phase studies into.
• Provided industry Leadership as Team co-Leader for the CDISC Submissions Data Standards (SDS), leading the team through the creation and publication of 2 new releases of the SDTM standard (www.cdisc.org/sdtm) for.
• Delivered the Procedural Document Framework and established Governance Team to manage Clinical Study Procedural Documents (including Biometrics), bringing the Clinical Organization within single document hierarchy and.
• Led cross-functional teams through implementation of 1 Document Management System (DMS) for MedImmune Biologics and 2 new Learning Management Systems (LMS) for AZ R&D, including delivery of Support Model, Training, and.
• Received 2018 MedImmune Senior Executive Team Global Excellence Award for implementing the Learning Management System (LMS) & Learning Curricula Simplification initiative (classifying, tagging & indexing LMS content as.

Cambridge, Cambridgeshire, GB

• Responsible for leading Clinical Development to optimize the management of Clinical Information. Develop and implement the 3-5 year Clinical Information Management Strategy. Deliver and implement the Information.
• Delivered and implemented the Information Strategy Roadmap for Clinical Trial information with approved Business Cases for recommended Improvement Initiatives, created Data Standards Governance framework, and.
• Established collaborative model with IS/IT organization for stabilizing and integrating the technical infrastructure, rollout and decommissioning of systems, and defining requirements in support of Regulatory.
• Led Clinical Development functions in global e-Archive and Information Security initiatives, organizing engagement levels for Clinical Development through Business Reference and Management Teams to define requirements.

Dublin 2, IE

• Experience relates to an Accenture Acquisition: Octagon Research SolutionsResponsible for developing new line of business in Biometrics and Clinical Trial Data Management, Analysis, and Reporting services for all TAs..
• New business unit created, generating 1st year earnings: +$1M

Cambridge, Cambridgeshire, GB

• Responsible for providing Statistical Programming & Clinical Data Management staffing support to multiple Drug Projects in the CVGI Therapy Areas for all phases of product life-cycle such as INDs, NDA/sNDA Submissions.
• Provided strategic interpretation and guidance for NDA/sNDA Electronic Submissions RoadMap
• Provided industry leadership and enhanced Data Standards presence in emerging CDISC initiatives & Teams, became a key member of the CDISC SDS Team member that developed the industry-wide SDTM Standard, became Chair of.
• Led Programming & Data Management team through 6 NDA and 6 s-NDAs, all delivered to plan resulting in approval.
• Led Biometrics team through successful FDA Advisory Committee Meeting.
• Developed first, company-wide Electronic Submission Data Standards in compliance with FDA’s 1999 e-Submission Guideline

Greenwich, CT, US

• CDISC Analyst – Bayer HealthCare Pharmaceuticals Inc (CDISC Consulting)
• SAS Analyst – Walklett Burns, Ltd. (Assignment: Centocor, Inc.)
• SAS Analyst – Research Data Corporation
• SAS Analyst – Arms, Inc. (Assignment: McGraw Hill, Publishing)
• Programmer Analyst – Computer Science Corporation