Job Details

Company Description

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on eye health. As a Japan-originated, global company with our footprint in over 60 countries and regions, our mission is to provide essential and significant value to patients and society through our products and services created from our expertise in ophthalmology and from the patient's perspective. Santen Inc., located in Emeryville, CA (North America HQ), serves as an important global research and development hub for the organization which includes global manufacturing sites in Miami, Fl and Goleta, CA.

Job Description

The primary responsibility of this position is to provide statistical support to clinical projects across multiple disease areas at Santen Inc. Additional responsibilities include facilitating the execution and data analysis of clinical trials and data collection activities. This position assists the Study Statistician in directing the programming and data management team during the collection, electronic storage, manipulation and execution of the analysis of all clinical data using clinical information systems.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

• Provides statistical support to the planning, implementation, and maintenance of clinical data collection and analysis, statistical result reporting, and quality control for Santen clinical trials.
• Works closely with clinicians and Study Statistician to write Statistical Analysis Plans (SAP).
• Performs exploratory statistical analysis to meet the needs for planning and clarifying purposes.
• Works closely with SAS programmers and Study Statistician to create SDTM and ADaM specifications, datasets and reports.
• Provide statistical supports for Global Medical Affairs group for publications and presentations.
• Exploratory analyses and/or AI/ML on clinical data and / or Real World Data

Qualifications

• MS degree in Biostatistics with preferably three plus (3+) years of experience or Ph.D. with preferably two plus (2+) year of experiences.
• Pharmaceutical or related experience with clinical trials.
• Understanding of clinical trial data and extremely hands-on in analysis and reporting of clinical trial data.
• Strong SAS programming skills; Proficiency in R and Python is a plus, but not required
• Basic knowledge of Electronic Data Capture system and CDISC standards including SDTM and ADaM.
• Experience with AI/ML on large datasets is a plus, but not required.
• Excellent verbal, written and organizational skills.

Additional Information

What we offer:

This is a contract position. The Hourly Rate for this contract is $76 - $104 per hour depending on experience.

Grow your career at Santen

A career at Santen is an opportunity to make a difference. We aspire to contribute to the realization of "Happiness with Vision" by providing eye health products and services to patients, consumers, and medical professionals around the world. Guided by our CORE PRINCIPLE, "Tenki ni sanyo suru", Santen is engaged in the global research & development, manufacturing, and sales and marketing of pharmaceutical products in ophthalmology. 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.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.