VP, Data Science

Location
Emeryville, CA, United States
Posted
Nov 13, 2020
Ref
1038
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY DESCRIPTION:

At Santen, we’re innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field—through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. Now, and into the future. As a global company, Santen is often expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network now spans three continents, with centers in Europe, Japan, and the United States.

ABOUT THE POSITION:

The Vice President of Global Data Science is responsible for leading, implementing and managing the biostatistics, statistical programming and data management programs at Santen Inc. and to facilitate the design, execution, and data analysis of clinical trials and data collection activities. This position is furthermore responsible for the creation, collection, electronic storage, analysis, and reporting of all Clinical data using clinical information systems as well as utilizing external data to improve predictability of future trials (REW, M&S etc.). Oversight and supervision of a global workforce spread throughout US, Europe and Japan.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

Key Deliverables:
  • This role is accountable to create and support a collaborative, global Data Science Function and mindset
  • Build, define and grow the data science strategy and team to deliver best-in-class capabilities that will support Santen’s growth goals. Also develop key metrics to showcase the growth to next level
  • Raise the visibility of Data Science function globally
  • Enable, empower and develop Data Science management team in day-to-day efforts and strategies

Behaviors that will drive success include:

Leadership:
  • Effectively collaborates with preclinical, clinical research & clinical development so that Data Science resources and deliverables meet and exceed their expectations of context, project team participation and behavior, quality and timeliness of deliverables
  • Effectively collaborates with Global Research, Global Development including Global Medical Affairs to ensure global transparency on clinical trial data from GR & GDev. sponsored studies, and ensures proper data utilization with regards to any post-hoc analyses within and across clinical trials. Accountable to develop and deploy rules of data governance, regulating access to and analytical use of Santen owned data
  • Effectively collaborates with Regulatory Affairs to ensure optimal strategic and quality input and delivery in planning of clinical development strategies, execution of clinical trials and in the preparation, participation and submission of relevant regulatory dossiers, documents, presentations, responses and specialty publications

Strategic and Innovative thinker with roll up the sleeves behaviors:
  • Develop and implement annual Global Data Science specific objectives and plans. Participates in development of 3-5 year mid-term plans
  • Responsible for assuring the maintenance and compliance of Data Science specific standards, processes, SOPs, training and quality control, to the highest level of compliance with ICH, GCP and Santen policies
  • Strong change management strategy and experience including new product development, project management and workflow enhancements
  • Develop and implement Statistics specific optimized processes and ensure alignment of these processes with other intra and cross functional processes that enable optimal drug development and support at Santen
  • Ensure alignment with other global functions, Global Pharmacovigilance, Regulatory Affairs, Biomedical Sciences, Global Medical Affairs and Global Clinical Development in the development of clinical development plans, protocols, CSR, ISS and ISE standards and processes
  • Develop and implement processes for the growth, health and support of the Global Data Science Function and resources including HR, financial, information solutions and administrative support
  • Contributes to the development and maintenance of (global) platforms, solutions and vendor relationships for the design, capture, analysis, integration and reporting of drug development related data; for the use of relevant external data, and data models

Strong Technical Ability:
  • Participate in development and maintenance of competency framework, training programs, and attract and retain best in class Statistics, Programming, and Data Management expertise at the biometrics function at Santen
  • Participate in implementation of optimal organizational structure which maximizes on the use of resources globally and reflects the therapeutic area focus at Santen
  • Solid experience in Data Mining
  • Contribute to protocols, statistical analysis plans and data presentations for all Santen Inc. clinical studies and pre-clinical studies (as needed)
  • Interface with Global IT and Regulatory Affairs

QUALIFICATIONS:

Core competencies, education, and experience:
  • Ph.D. in Statistics, Biostatistics, or equivalent required
  • Previous experience working within a Japanese organization preferred
  • Previous Pharmaceutical experience
  • Minimum of fifteen plus (15+) years experience required in managing a statistical, biostatistics and/or data management group, preferably in ophthalmic research and development
  • Thorough knowledge of statistics as it applies to clinical trials
  • Previous experience with:
    • Biostatistics
    • Analytics
    • Study Design
    • All aspects of protocol
    • Global Registration
  • Experience with Clinical Data Management packages (i.e. Medidata Rave, Oracle InForm, etc.)
  • Experience communicating and influencing senior management and with the FDA, PMDA, EMEA and other Global HAs
  • Ability to change the thinking of or gain acceptance of others in sensitive situations
  • Ability to make high level decisions and work cross-functionally with others as a team. Proven ability to manage through teamwork
  • Experience leading and unifying global projects and teams a must
  • Ability to travel approximately 10-25%

WORK ENVIRONMENT AND ENVIRONMENTAL CONDITIONS:

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

For more information about our company and the work experience, please visit www.santenusa.com