Resume
Experience
2021-09 - Present
Director of Biostatistics
GSK Consumer Healthcare
Warren, NJ
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Provide scientific and technical statistical leadership on studies from non-clinical development planning through to publication, where appropriate
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Interacts with senior internal and external stakeholders on statistical issues
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Provides technical leadership and expertise to guide Statisticians when challenges arise in clinical studies and liaise with other business units and/or statistical experts for those situations
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Work as a Study Statistician on more complex projects, including submission projects and as required partake in escalation/troubleshooting activities
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Co-ordinate and lead all Biostatistics and Data Management (BDM) activities for projects, where appropriate
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Lead functional and cross-functional process improvement initiatives
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Provide Third Party oversight of strategic and tactical partners as related to area of responsibility
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Provide expert statistical knowledge and leadership for activities to support the business outside of clinical studies, such as due diligence, complaint/challenge and training
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Coaches and mentors junior staff across BDM
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Provides expert statistical input and leadership in relation to clinical trials, real-world evidence and other statistical work executed by the Consumer Healthcare division across multiple categories, including detailed regulatory interactions.
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Accountable for the successful execution of the delegated projects and provide leadership of oversight of Third-Party Vendors
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Deputize for Head of BDM on reviews/approvals and other interactions.
2005-11 - 2021-09
Manager, Biostatistics
GSK Consumer Healthcare
Warren, NJ
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Reviewed and approved protocols, SAPs, CSRs, and publications
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Developed scalable IVIVC models in lieu of BE studies for manufacturing sites and formulations changes.
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Lead the QTLs initiative in line with ICH E6 R2 requirements for data integrity and subject safety
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Lead departmental process improvement initiatives of streamlining and ownership of written standards.
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Provided statistical leadership on RWD/RWE and MDR PMCF studies.
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Effectively and timely responded to requests from regulatory agencies and other stakeholders
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Prepared integrated summaries of safety and efficacy
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Lead statistician on FDA Advisory Board Meetings
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Oversaw Junior statisticians by providing mentoring
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Provided vendor oversight for Statistics deliverables
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Authored SAPs for analyses done in house
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A trusted SME on complex Statistics methodologies
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Developed a vendor selection process.
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Due diligent vendor qualification assessments.
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Statistics lead of clinical support for market expansions
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Internal Statistics consultant on studies & literature
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Oversee the data disclosure efforts
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Developed vendor payment models.
2004-05- 2005-11
Senior Statistician
Unilever
Trumbull, CT
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Enabled the delivery of effective technically defensible, informative, and timely study designs.
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Leveraged critical thinking in statistical design, sampling, and data analyses
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Worked on retrospective meta-analysis to gain efficiencies of evaluating Anti-Aging technologies
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Scouted, identified, and championed novel, value-added data-analytical methodologies.
Education
2003
Ph.D.: Statistics
Kansas State University
Manhattan, KS
2015
MBA
Montclair State University
Montclair, NJ
1998
Master of Science: Mathematics & Statistics
Western Illinois University
Macomb, IL
1996
Bachelor of Science: Mathematics & Statistics
The University of Nairobi Nairobi, Kenya
Professional Skills
Exemplary interpersonal communication skills
Strong team leadership capabilities
Third-party Vendor relations and management
Software
Spotfire
Power BI
nQuery
SAS
PASS
R
GastroPlus
Accomplishments
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Developed scalable In Vitro In Vivo Correlation models following FDA and EMA regulations in lieu of a clinical BE study that will speed the Transderm Scōp® patch to market with savings
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Successful integration of GSKCH and Novartis CH integration after a Joint Venture
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Enabled strategies that improved first time acceptance of study results disclosures to https://clinicaltrials.gov/from 38% to over 80% and 100% second time
Affiliations
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American Statistical Association
