Wayne Woo Email & Phone Number

Gaithersburg, Md, Us

Gaithersburg, Maryland, Us

Gaithersburg, Maryland, Us

Gaithersburg, Maryland, Us

Just getting started.

Brentford, Middlesex, Gb

I have structured my work experience description to reflect one entry per title/location. Tenure counted at GSK has spanned 2 acquisitions and 2 geographic moves and totals over 19 years. Current role of Expert Biostatistician (equivalent to Principal Biostatistician) encompasses providing statistical support to design and execution of clinical studies and regulatory submissions in collaboration with clinicians, epidemiologists, safety scientists, programmers, data managers, medical writers, regulatory, and fellow statisticians. This includes oversight of CRO statistical activities when studies are executed in an outsourcing mode. Also participation in process improvement teams and specialized task forces. Concurrent enrollment in graduate Biostatistics program.

Brentford, Middlesex, Gb

I was given the title of Biostatistician to start my official role as a clinical trials statistician. Work included statistical input to sBLA for seasonal influenza vaccine and statistical support for studies of RSV vaccine and pandemic flu vaccine. Concurrent enrollment in graduate Biostatistics program. Relocation to Maryland.

Brentford, Middlesex, Gb

I carried this title into the integration of Novartis Vaccines with GSK Vaccines. I contributed to efforts around patient-level data sharing, ADAM implementation, and risk-based monitoring.

Led or contributed to efforts on functional outsourcing, data disclosure and patient-level data sharing, SOP development, data standards implementation, regulatory submissions, training of statistical programmers. Maintained occasional hands-on SAS programming.

I assumed this title as I finished master’s studies in management. The role primarily involved operational management of a geographically distributed global team of statistical programmers working on analyses of clinical study data. Worked on training and integrating Hyderabad team in addition to overseeing and developing established teams in US and EU.

This title was recognition of an oversight role for the centralized SAS programming environment that served global statistical computing needs. This included hands-on contribution to maintenance of the system as well as strategizing improvements. This latter component included a key role in the overhaul of the statistical computing framework encompassing introduction of SAS Drug Development, adoption of CDISC data standards, update of reporting tools and reworking of business processes. In addition to this main role, I was team lead overseeing statistical programming work for the company’s meningitis vaccine candidate, and also training/developing geographically dispersed programmers.

I maintained this title through a stretch of time while Chiron was integrated into Novartis. Relocation to Cambridge in July 2017. In this role, I began my journey into vaccines development. Worked in a statistical programming capacity on menigitis vaccine and H1N1 pandemic vaccine. Was part of team for several product approvals. Specific projects included dataset packages for FDA, interactive response systems for randomization, TFL generation, SAS environment maintenance, training and overseeing a few programmers, participate in process improvement, involvement in industry meetings, etc.

Emeryville, California, Us

I was promoted to this title upon completion of the project to migrate the SAS computing environment from VMS to Windows. The main responsibilities of this role were to guide the steady-state maintenance of the system, identify and implement improvements, liaise with IT, and hand-on support of any other SAS or technical work as needed.

Emeryville, California, Us

Promotion to recognize work primarily focused on biometrics systems and processes rather than TFL generation. In this role, I led the technical project of migrating the SAS computing enviroment from VMS to Windows.

Emeryville, California, Us

This was a hands-on statistical programming role in a clinical trials setting. I worked on TFLs for sepsis and HIV studies, as well as improvements to SAS standard macros, an in-house phone-based IRT and department web-based report delivery system. I also was tasked to learn about the evolving CDISC standards and keep the managers and team informed.

SAS, Visual Basic, Java programming and development in a clinical trials setting. Both applications programming and analysis of clinical data.

Arlington, Va, Us

Data analysis, report generation, applications building using SAS. Working with data pertinent to decision makers in Department of Defense.

Master Of Science (M.S.), Biostatistics

Alm (Masters Of Liberal Arts), General Management Studies

Ba, Mathematics