At Santen, they’re innovating therapies to improve the quality of life for patients worldwide. Their single focus in ophthalmology enables them 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. Their 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 implementing and managing biostatistics, data management and programming at Santen Inc. to facilitate the design, execution, and data analysis of clinical trials and data collection activities. Responsible for the 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, Japan and China.
Essential Duties And Key Deliverables
- Develop and implement annual biometrics specific objectives and plans. Participates in development of 3-5 year mid-term plans
- Responsible for assuring the maintenance and compliance of Statistical specific standards, processes, SOPs, training and quality control, to the highest level of compliance with ICH, GCP and Santen policies.
- Effectively collaborates with preclinical, clinical research & clinical development so that Statistical 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.
- Participate in development and maintenance of competency framework, training programs, and attract and retain best in class Statistics expertise at the biometrics function at Santen. Responsible for the development and maintenance of competence and training for the Statistics competencies.
- Participate in implementation of optimal organizational structure which maximizes on the use of resources globally and reflects the therapeutic area focus at Santen.
- 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 upport 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 Statistics 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.
- Develop and implement resource algorithms and performance goals by role. Ensure optimal planning and allocation of internal resources.
- Develop and maintain optimal solutions for functional service provider relationships with appropriate quality and oversight to ensure flexibility and agility in the allocation and management of internal and external resources
- Develop protocols, statistical analysis plans and data presentations for all Santen Inc. clinical studies and pre-clinical studies (as needed)
- Play a key role in the preparation of reports, presentations and publications furthering Santen’s scientific expertise.
- Creates a unique vision for Santen’s Data Science department to deliver on big data ambition and leads its interdependencies across the organization.AND
Core compentencies, education, and experience.
- Ph.D. in Statistics, Biostatistics, or equivalent required
- Minimum of 15+ years experience required in managing a statistical and/or data management group, preferably in ophthalmic research and development
- Thorough knowledge of statistics as it applies to clinical trials
- Excellent knowledge of SAS and ability to adapt statistical methodology to specific applications and develop computer programs for analysis
- Excellent verbal, written, organizational and SAS programming skills
- Experience with Clinical Data Management packages (i.e. Clintrial, Oracle*Clinical, etc.)
- Experience communicating with senior management and with the FDA, 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 with others as a team
- Proven ability to manage through teamwork
- Experience on global projects must
- Ability to determine when to use internal resources or a CRO; experience managing outside consultants/CRO’s preferred
- Ability to travel approximately 30%
For more information about their company and the work experience, please visit www.santenusa.com
- Salary Offer 0 ~ $3000
- Experience Level Junior
- Total Years Experience 0-5
- Dropdown field Option 1