Experience

PureTech Health

• United States
• Biotechnology
• 1 - 100 Employee

• Vice President, Biostatistics

  • May 2022 - Present

  Doing my best today (as a biostatistician) for better tomorrow in health care industry - working to have better options available for patients and their care givers. Be calm, be kind, collaborate, and help others. Doing my best today (as a biostatistician) for better tomorrow in health care industry - working to have better options available for patients and their care givers. Be calm, be kind, collaborate, and help others.



Gyroscope Therapeutics

• United Kingdom
• Biotechnology Research
• 1 - 100 Employee

• Vice President of Biostatistics

  • Jan 2021 - Apr 2022

  Reporting to CMO Provide hands-on & strategic support for biostatistics & statistical programming Build inhouse biostatistics & statistical programming capability Manage inhouse and CRO activities related to biostatistics, statistical programming, and data management Support safety review, data review, publication, and due diligence activities Reporting to CMO Provide hands-on & strategic support for biostatistics & statistical programming Build inhouse biostatistics & statistical programming capability Manage inhouse and CRO activities related to biostatistics, statistical programming, and data management Support safety review, data review, publication, and due diligence activities



Apellis Pharmaceuticals

• United States
• Biotechnology Research
• 500 - 600 Employee

• Sr. Director of Biostatistics

  • Mar 2020 - Nov 2020

  Provide strategic leadership and hands-on biometrics support for COVID-19 and Geographic Atrophy (GA) program Manage inhouse and CRO activities related to biostatistics and SAS programming Accomplishment: IND submission with COVID-19 program; authored SAP for phase 3 studies in GA program; support publication work Provide strategic leadership and hands-on biometrics support for COVID-19 and Geographic Atrophy (GA) program Manage inhouse and CRO activities related to biostatistics and SAS programming Accomplishment: IND submission with COVID-19 program; authored SAP for phase 3 studies in GA program; support publication work



Solid Biosciences

• United States
• Biotechnology Research
• 1 - 100 Employee

• Sr. Director of Biostatistics

  • Nov 2019 - Mar 2020

  Provided hands-on biometrics support for manufacturing, pre-clinical and clinical studies Managed CRO activities related to biostatistics, SAS programming, and data management Accomplishment: helped summarize & better understand the existing data in the lead program (AAV micro-dystrophin gene therapy) Provided hands-on biometrics support for manufacturing, pre-clinical and clinical studies Managed CRO activities related to biostatistics, SAS programming, and data management Accomplishment: helped summarize & better understand the existing data in the lead program (AAV micro-dystrophin gene therapy)



Alcon

• Switzerland
• Medical Equipment Manufacturing
• 700 & Above Employee

• Sr. Franchise Lead Statistician

  • Jan 2015 - May 2019

  Oversee and represent all statistics-related activities in intraocular lens (IOL) projects Scientific, strategic, technical, and operational leadership and management of accountable therapeutic area in support of all projects in IOL franchise. Provide statistical representation and leadership in project teams Supervision and mentoring of biostatisticians Oversee and represent all statistics-related activities in intraocular lens (IOL) projects Scientific, strategic, technical, and operational leadership and management of accountable therapeutic area in support of all projects in IOL franchise. Provide statistical representation and leadership in project teams Supervision and mentoring of biostatisticians



Lexicon Pharmaceuticals, Inc.

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Director of Biostatistics

  • Jul 2013 - Jan 2015

  Serving as a statistical lead in oncology therapeutic area Providing statistical guidance on clinical development plan Oversee and represent all statistics-related activities Serving as a statistical lead in oncology therapeutic area Providing statistical guidance on clinical development plan Oversee and represent all statistics-related activities



Hospira

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Director, Biostatistics

  • Jun 2011 - Jun 2013

  Serving as a therapeutic area lead statistician in oncology biosimilar programs (filgrastim, pegfilgrastim, epoetin, and rituximab) Manage internal and external statisticians and SAS programmers who support the project teams. Participate in regulatory submission and interactions with the FDA/EMA Provide statistical representation and leadership in project teams. Serving as a therapeutic area lead statistician in oncology biosimilar programs (filgrastim, pegfilgrastim, epoetin, and rituximab) Manage internal and external statisticians and SAS programmers who support the project teams. Participate in regulatory submission and interactions with the FDA/EMA Provide statistical representation and leadership in project teams.



Astellas Pharma US

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Director, Biostatistics

  • 2008 - Feb 2011

  Therapeutic Area (TA) Lead in Oncology Biostatistics Solid tumors: breast, lung, melanoma, prostate Liquid tumors: AML, B-cell NHL Scientific and operational management for a portfolio of projects in oncology Due Diligence for in-licensing Responsible for all statistical work within oncology biostatistics Contributes, reviews and approves documents related to statistics (Clinical Development Plans, Statistical Analysis Plans, Protocol, Research Reports, Integrated Reports, Manuscripts, Regulatory Submissions) Supervision and mentoring of biostatisticians Manages personnel resourcing Participate in CRO management (e.g., vendor selection, selection of functional service provider, etc.) Development & Review of SOPs & WPIs Astellas Star Team Awards, oncology in-licensing team, 2010