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 fieldthrough 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. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States.
We are in search of top talent to help us meet our aggressive and important goals.
ABOUT THE POSITION:
This position is responsible for implementing and managing statistical programming activities; developing, validating and maintaining statistical software (SAS programs) in support of statistical programming to be used for monitoring, analyzing and reporting of clinical trials data for regulatory submissions and publications across multiple disease areas at Santen. This position will also include activities related to the development and maintenance of all standard operating procedures related to statistical programming and CDISC standard implementation. This position may include direct reporting of Statistical Programming team members.
ESSENTIAL DUTIES AND KEY DELIVERABLES:
Applies advanced level programming techniques to plan, implement, and maintain programs for the monitoring, reporting, and analysis of Santen's clinical trials and ad hoc requests
Independently provides technical and project management leadership for SAS programming team activities, within budget and timeline constraints while assuring quality standards
Provides leadership to study teams solve problems related programming tasks in non-routine situations
May be required to provide additional validation support of key deliverables to ensure quality standards.
Provides study level resourcing assignments and assists Head of Statistical Programming in global resourcing decisions
Participate on project teams as Lead Statistical Programming to provide guidance and input regarding programming activities and timelines
Manage CRO programming activities and review deliverables as needed
Develop and manage a staff of up to 5 programmers by assessing and providing appropriate training, setting goals, coaching, and recognizing those who make significant contributions to business objectives.
Contribute to the development, implementation and maintenance of global programming procedures, tools and practices to ensure departmental efficiency and consistency with industry best practices (i.e. CDISC standard procedures)
Responsible for understanding the impact of industry and company strategies on the programming department and deliverables.
Attend professional meetings and job-related training sessions when requested and as appropriate
Participation in recruiting processes and logistics to hire individual contributors
Other duties may be assigned as needed
Minimum of 12+ years of SAS programming with 5+ years of pharmaceutical industry experience, with ophthalmic pharmaceutical industry experience preferred.
BS degree or higher and more than 2+ years serving as a lead programmer, mentoring staff and coordinating the work of programming teams. Experience may be substituted for education requirement.
Knowledge of registration filing requirements for statistical programming. Experience in multiple FDA and EMEA filings is preferred.
Advanced SAS programming skills.
Good communication skills.
Knowledge of basic statistics and ability to communicate with statisticians and sometimes non-statisticians to verify and interpret tables, listings, figures.
Good organizational and problem-solving skills.
Must work effectively and independently in a team environment.
Experience in reviewing study planning documents such as Statistical Analysis Plans.
Knowledge of good programming procedures.
Ability to lead statistical programmers to work on multiple projects simultaneously.
Excellent communication skills and collaborative working style is essential.
For more information about our company and the work experience, please visit www.santenusa.com