Worked as a team member in all phases of the drug development process. Worked as a statistician on completing the analyses required for the CTRs of a number of studies in Phase 1 and Phase 3. Reviewed study documents for accuracy and ensuring that results supported the conclusions of the study report.Provided statistical assistance to the Marketing group.Supported the completion of CSRs and publications arising from these studies, by reviewing and providing… Show more Worked as a team member in all phases of the drug development process. Worked as a statistician on completing the analyses required for the CTRs of a number of studies in Phase 1 and Phase 3. Reviewed study documents for accuracy and ensuring that results supported the conclusions of the study report.Provided statistical assistance to the Marketing group.Supported the completion of CSRs and publications arising from these studies, by reviewing and providing comments and suggestions on articles, abstracts or posters arising from these studies.Provided support for Market Access activities for a new drug by providing subgroup analyses for different patient populationsProvided technical leadership for other statisticians in the local office; this was done by making presentations and providing input on statistical analyses. Lead internal and external statisticians and SAS programmers who support the project teams. Show less

Provide leadership to the legacy Organon CNS team by ensuring that trials are well designed and the analyses are geared towards the objectives of the protocol.Coordinate and review responses to requests from regulatory agencies Assist with the planning of protocols for new indicationsProvide statistical leadership to direct reports to ensure that adequate services are provided to our clinical colleaguesEnsure that new tasks are adequately resourced and that… Show more Provide leadership to the legacy Organon CNS team by ensuring that trials are well designed and the analyses are geared towards the objectives of the protocol.Coordinate and review responses to requests from regulatory agencies Assist with the planning of protocols for new indicationsProvide statistical leadership to direct reports to ensure that adequate services are provided to our clinical colleaguesEnsure that new tasks are adequately resourced and that statistical activities are performed in compliance with corporate standards Show less

10/2010 – 3/2012, 3/2012-9/2012Provide leadership to the legacy Organon CNS team by ensuring that trials are well designed and the analyses are geared towards the objectives of the protocol.Coordinate and review responses to requests from regulatory agencies Assist with the planning of protocols for new indications

Supervise a department of statisticians and programmers in the absence of the Senior Director of BiometricsAppoint members to teams in order to ensure adequate resources and high quality statistical support for ongoing and upcoming projectsLead a CNSt eam in successful preparation for the Advisory committee meetingPerform critical review of statistical analyses and statistical plans developed by team members to ensure that all aspects of the projects are of high a… Show more Supervise a department of statisticians and programmers in the absence of the Senior Director of BiometricsAppoint members to teams in order to ensure adequate resources and high quality statistical support for ongoing and upcoming projectsLead a CNSt eam in successful preparation for the Advisory committee meetingPerform critical review of statistical analyses and statistical plans developed by team members to ensure that all aspects of the projects are of high a qualityServe as Global Project Statistician for the Insomnia projectProvide colleagues from Regulatory, Clinical, Medical Affairs and other disciplines within our organization with expert statistical advice on ongoing projectsCoordinate responses to the FDA and other regulatory agencies in order to address and solve statistical issues Show less