Resume

Experience

2021-09 - Present

Director of Biostatistics

GSK Consumer Healthcare

Warren, NJ

  • Provide scientific and technical statistical leadership on studies from non-clinical development planning through to publication, where appropriate

  • Interacts with senior internal and external stakeholders on statistical issues

  • 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

  • Work as a Study Statistician on more complex projects, including submission projects and as required partake in escalation/troubleshooting activities

  • Co-ordinate and lead all Biostatistics and Data Management (BDM) activities for projects, where appropriate

  • Lead functional and cross-functional process improvement initiatives

  •  Provide Third Party oversight of strategic and tactical partners as related to area of responsibility

  • Provide expert statistical knowledge and leadership for activities to support the business outside of clinical studies, such as due diligence, complaint/challenge and training

  • Coaches and mentors junior staff across BDM

  • 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.

  • Accountable for the successful execution of the delegated projects and provide leadership of oversight of Third-Party Vendors

  • Deputize for Head of BDM on reviews/approvals and other interactions.

2005-11 - 2021-09

Manager, Biostatistics

GSK Consumer Healthcare

Warren, NJ

  • Reviewed and approved protocols, SAPs, CSRs, and publications

  • Developed scalable IVIVC models in lieu of BE studies for manufacturing sites and formulations changes.

  • Lead the QTLs initiative in line with ICH E6 R2 requirements for data integrity and subject safety

  • Lead departmental process improvement initiatives of streamlining and ownership of written standards.

  • Provided statistical leadership on RWD/RWE and MDR PMCF studies.

  •  Effectively and timely responded to requests from regulatory agencies and other stakeholders

  • Prepared integrated summaries of safety and efficacy 

  • Lead statistician on FDA Advisory Board Meetings

  • Oversaw Junior statisticians by providing mentoring

  • Provided vendor oversight for Statistics deliverables

  • Authored SAPs for analyses done in house

  •  A trusted SME on complex Statistics methodologies

  • Developed a vendor selection process.

  • Due diligent vendor qualification assessments.

  • Statistics lead of clinical support for market expansions

  • Internal Statistics consultant on studies & literature

  • Oversee the data disclosure efforts

  • Developed vendor payment models.

2004-05- 2005-11

Senior Statistician

Unilever

Trumbull, CT

  • Enabled the delivery of effective technically defensible, informative, and timely study designs.  

  • Leveraged critical thinking in statistical design, sampling, and data analyses

  • Worked on retrospective meta-analysis to gain efficiencies of evaluating Anti-Aging technologies

  • Scouted, identified, and championed novel, value-added data-analytical methodologies.
     

Education

2003

Ph.D.: Statistics

Kansas State University

Manhattan, KS

Kansas State University,Manhattan, KS.jp

2015

MBA

Montclair State University

Montclair, NJ

Montclair State University,Montclair, NJ

1998

Master of Science: Mathematics & Statistics

Western Illinois University

Macomb, IL

Western Illinois University,Macomb, IL.j

1996

Bachelor of Science: Mathematics & Statistics

The University of Nairobi      Nairobi, Kenya

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

  • 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

  • Successful integration of GSKCH and Novartis CH integration after a Joint Venture

  • 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

  • American Statistical Association

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Additional Information

President and CEO of Hamisi Community Development Fund, Inc., a non-profit organization