Clinical data analysis and reporting, data validation, software validation.

• Provides Biometrics leadership for all investigational products. • Specification and generation of statistical tables, listing, and figures for Phase II and III studies.• Develop Data Visualization applications and reporting tools in R/Python for several studies.• Responsible for managing and executing the design, testing, implementation, analysis, and documentation of the clinical database activities (Several Phase I, Phase II, and Phase III pivotal study)• Oversee or execute Data Management Plan, Case Report Form and Completion Guideline development and approval.• Oversight of data review activities and manage all activities leading to the study database lock, including generating data listings, data visualization, patient profiles and had-hoc analyses. • Prepare the Data Transfer Agreements (DTA) or oversee the development of DTA between the Data Management CRO and the External data vendors.• Review and generation of tables, listing, and figures.• Developed data workflow from vendors to ensure automatic feed for data processing pipelines.• Performed several post-hoc data Analysis in R/Knitr and Python/Pandas/Jupyter/Seaborn to pre-dict Sinus Rhythm conversion. Restriction Analysis, Binary and Multinomial Logistic regression, model fitting.• Provided programming and statistical support for several conference presentations and scientific articles.

Corcept Therapeutics Inc. is a pharmaceutical company engaged in the discovery, development, and commercialization of drugs for the treatment of disorders due to adverse effects of excess cortisol. • Responsible for 6 studies in Corcept Cushing and Metabolic programs; two study builds on time within the first 3 months of employment. One direct report.• Managed data management service providers (vendors) to ensure the quality of deliverables and that timelines are met. • In charge of Medidata URL and core configuration management: contract negotiation, process-es and SOP development, training and implementation, main SME for the team.• Ensured optimized data collection, flow and access across EDC and non-EDC data sources.• Developed critically assesses data metrics and suggested process improvement • Responsible for accuracy, completeness and CDISC compliance of clinical databases. • Development and/or review of SDTM datasets.• Reviewed and selected and tools enabling real-time data visualization, interrogation, and reporting. • Reviewed study protocols to ensure that data collection and CRF design meet study objectives • Managed and oversaw SAE reconciliation between clinical and pharmacovigilance database

CytomX Therapeutics is a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of monoclonal antibodies including PD-L1, CD166, CTL-4, and CD71 targets. • Oversight of clinical data management activities across 3 studies and within the department.• Development and maintenance of Case Report Form (CRF), CRF Completion guidelines, edit check specifications, data transfer specifications, and database audit plans. • Development of Medidata Rave EDC database and Balance/RTSM randomization and supply management system, including change controls and migrations.• Performed and organized cross-functional User Acceptance Testing (UAT) of the integrated clinical databases.• Work with clinical, biostatistics, and regulatory teams to design and develop study documents including Clinical Protocol, Case Report Forms (CRFs) and Statistical Analysis Plan (SAP).• Involved in the RFP process including the evaluation of potential vendors.• Development and implementation of departmental policies, standards and process improvement initiatives.• CRO data management functions inspections and audits.

The European Organisation for Research and Treatment of Cancer (EORTC) brings together 5500 European cancer clinical research experts from 930 institutions in 27 countries for transnational collaborations in cancer treatment and research.• Line management for up to six local programmer-analysts and validation specialists, and sever-al remote resources.• Lead the EDC transition to Medidata/Rave company-wide over 18 months, including vendor se-lection, audit, project management, implementation, training, piloting and production.• Involved in DM processes implementation including CDASH DB implementation, data transfer, DB migration.• Oversee Rave custom functions development, testing, and deployment. • Oversee several other system implementations including vendor selection and validation.• Lead in-house development projects and vendor selection for companywide systems. • Maintenance of existing local applications.• In charge of developing new system using web-based technologies.• Develop and implement Information Systems Strategy.• Implement vendor selection processes.• Develop custom reports using R, BO, Python.• Computer System Validation following GAMP 5 for internal and external applications, including User and System Requirement Specifications, Tests protocols Specification and Execution, Val-idation Reports.

• CDISC SDTM/ADaM specialist, Business Decision Life Sciences: data coding, listing generation, CDISC review and validation (8 months, Brussels).• Clinical Management Specialist, Biotroniks: study design and build in EDC including edit-checks validation (8 months, Zurich).• Manager, Clinical Data Management, Janssen - Johnson & Johnson: data cleaning, listing design and development (6 months, San Francisco)• CTO/Project Manager for a start-up using React, NodeJS, and MySQL (6 months, remote).• Senior Consultant for Clinovo: SAS programming, statistical analysis, data management (16 months, remote).

• Primary contact for several Medical Device (SCS, DBS) studies.• Manage Adverse Events and Concomitant Medication Coding (MedDRA, WhoDrug).• Creation of database specification, including CRF design and edit checks.• Development of DMP and DTP; Questionnaires licensing and translation.• Study builds in Medidata/Rave using Architect; ePRO implementation on iPAD.• Migration of studies, including development of UAT and validation plans.• Configuration of Medidata/Rave batch uploader for several studies. • Managing of data transfer and upload from faxed questionnaires.• Primary contact for several Medical Device (SCS, DBS) studies.• Develop and generate customized reports in R and SAS.

Responsible for all Clinical Operations including CDM, Biostatistics, SAS Programming, Medical Writing, and Project management operations (12 clients).Biometrics processes and deliverable (15 studies).EDC implementation and validation (6 new studies).Requirement Management, testing, and validation EDC systems, CDISC package management, and automatic XML data transfer.SAS programming management (more than 100 deliverables).Budget management (proposals, progress updates, and change orders).

• Develop, update, and integrate APIs to be used for authentication, search, geolocation, and other sub-systems.• Define test strategies, evaluate and test systems, analyze results and validate functionalities.• Write server-side code, develop prototypes and deploy robust high-volume production APIs. In-tegrate Oauth and OpenID systems.• Fix framework bugs and improve architecture, adding required unit, functional, and performance testing.

Database Lock activities (3 phase III studies).Dataset reviews, Outliers detection, Data controls.Data Review using Medidata Rave.Specifications and SAS programming to detect inconsistencies and generate queries.

Responsible for all clinical data operations, bio-statistical, and SAS programming operations.Concurrent activities: protocol review, screens design, data management plan, database design and testing, data entry support, data control management, database lock, data inspection, table and listing generation, statistical analysis, report review.Several vendor audits for GxP and part11 compliance: laboratory and data transfer, EDC systems and data hosting.CAPA management and several QA investigations including root cause analysis.Successful implementation of an EDC system: vendor choice, contract negotiation, vendor audit, customization, SOP development, training, UAT and system validation; hosted remote system based on Oracle/SQL and ASP/java; go live in December 2008.More than 50 electronic studies implemented mostly based on CDASH 1.0 standard, some of them based on sponsor specific standard.Developed a SAS CDISC compliant submission package that was used for several NDA submissions, based on FDA Study Data Specifications 1.5.1, and including define documentation, linked to blank CRFs, SDTM and ADaM datasets.Mapping and migration of several CRT submission packages to SDTM or sponsor standards, including hyper-linking of blank.pdf and define.pdf.

GEREQ was a McGill-affiliated project aimed at promoting Clinical Research among Canadian clinical sitesIn charge of all operations including compliance (ICH, GAMP, 21 CFR part 11) and Quality Assurance. Line Management: 6 direct reports, 50 indirect reports.Project development according to plan: setup of services, organized and trained 500 professionals in 20 investigative centers.Development and implementation of an EDC and a CDMS system, based on CDISC standards.SOP development, implementation, and personnel training.Launched 35 international clinical projects including 35,000 subjects. QA audits and compliance audits; ISO 9001:2000 certifications passed in 2005.Organized several audits, internal and external.

Created and managed a Company offering Clinical and Biometrics Services.Developed the Business Plan, Setup Administration and Management. Twelve employees and three years of positive earnings.Created an EDC system hosting of the first Internet studies in France including 10,000 subjects and 2,500 centers.Developed and exploited a CDMS including parallel double data entry.Built solid customer base, annual revenue increase: 20% to 30%.Clients: Aventis, Novartis, Novo-Nordisk, 3M, Lafond, Bayer, BMS, and Lilly.