Sr. Statistical Programmer

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health, and addressing vision-related social issues for people around the world. Santen USA, headquartered in Emeryville, Calif., is an important part of our worldwide efforts and is home to our regional business teams. We have about 350 total employees in North America, including our other offices located in Toronto, Canada, Fort Worth, TX and Miami, FL. For more, visit https://www.santenusa.com/.

This position is responsible for applying advanced programming techniques to support the development and validation of statistical programs to be used for monitoring, analysis and reporting of clinical trials data for internal decision-making, regulatory submissions and publications across multiple disease areas at Santen.  This position will also include activities related to the management of programming tasks and quality for deliverable associated with a clinical trial.

• Adheres to departmental procedures and practices, technical and industry standards and programming concepts and conventions during all aspects of work
• Applies advanced level programming techniques to the planning, implementation, and maintenance of programs for the monitoring, reporting, and analysis of clinical trials
• Serves as lead programmer, with responsibility for the timeline adherence and quality of all programming deliverables, for the assigned study
• Participates in the creation of SDTM/ADaM/TLF specifications, data definition files, and other documentation needed for submission to the regulatory agency
• Completes assigned programming tasks and documentation to meet quality and timeline expectations for the project
• Proactively identifies and resolves, or escalates, issues that could impact the quality or timely completion of a deliverable
• Participates in monitoring CRO activities and reviewing CRO deliverables as necessary
• Conducts program verification, identifies bugs and resolves technical problems
• Able to quickly gain an understanding of the study and processes to allow independent completion of assigned tasks
• Uses creativity to solve complex programming problems
• Contributes to the development, implementation and documentation of programming standards, templates, and conventions, to include identification of potential implementation issues
• Works with pre-clinical and clinical research staff to plan and query results for studies to support global development plans
• Contributes to the implementation of CDISC standards for Santen studies
• Serves as a Subject Matter Expert (SME) in Statistical Programming and participates in mentoring junior programmers
• Serves as an expert troubleshooter
• Opportunity to contribute to exploratory analysis, data mining, and machine learning activities using complex data from multiple sources

• B.S. and/or M.S. in Statistics, Biostatistics, Computer Science, Biotechnology, or closely related field.  Relevant experience can be substituted for education requirement
• Minimum of 5 years of SAS programming experience in a pharmaceutical research setting
• Ability to speak, read, write Mandarin is preferred
• Thorough knowledge of, and experience with, FDA/PMDA/EMA requirements and industry standards applicable to the design, conduct and analysis of clinical trials, including SDTM, ADaM, and eCTD requirements for regulatory submissions
• Advanced knowledge of SAS including Base, SAS/STAT, SAS/GRAPH and Macro Language.  Experience with additional software such as R or Python is preferred
• Ability to manage multiple tasks with competing timelines
• Excellent communication and interpersonal skills
• Ability to train and provide mentorship of others
• Ability to organize and manage the work of self and others.

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer.  We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

COVID-19 Vaccination Requirement: Santen requires anyone working on-site or visiting company offices to confirm they are fully vaccinated against COVID-19. Individuals who choose not to get vaccinated and who receive a job offer must follow Santen’s process for requesting a medical or religious exemption and subsequent accommodation. Please reach out if you have questions or concerns about this policy and how it may apply to your candidacy for a role with Santen.

For more information about our company and the work experience, please visit https://www.santenusa.com/career-culture.