Associate Director/ Director, Biostatistics

Industry: Research

Company: Santen

Company Description

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), serves as an important global research & development hub for the organization, and is home to about half of our North America employee population, which includes global manufacturing sites in Miami, Fl and Goleta, CA.

Job Description

Santen Inc in Emeryville is looking for an AD/ Director Biostatistics to join their team. The role is hybrid with a fixed number of days per week expected at office.

What you will do

The Associate Director (AD)/Director of Biostatistics will be responsible for coordinating, implementing and managing the biostatistics and clinical data activities as well as supporting the assigned clinical programs as the Lead Biostatistician.

Regarding clinical development the AD/Director will develop innovative clinical study designs and lead the effort to perform state of the art statistical analyses in collaboration with clinicians and other project team members from various functional groups at Santen.

Furthermore:

• The statistician will lead data mining and/or AI/ML of clinical or translational data, incorporation of Real World Data and/or digital data and/or imaging data into clinical development, clinical decision-making, and Health Authority interactions for their clinical programs. On the Director you may lead incorporation and analyses of new data types across clinical programs, therapeutic areas, and across regions.
• This statistician will closely work with the Head of Global Data Sciences, Global Biomedical Science, Clinical Science, Clinical Operation, Medical Affairs, Marketing and with project managers in providing strategic input to the product development plans and product differentiation, study designs, and product registration filings globally.
• The statistician supports the effort to develop and maintain all standard operating procedures related to statistical analysis, and to implement the CDISC standards. This position is also responsible for the analysis, visualization and reporting of all Clinical data of the assigned clinical programs.
• Depending on interest the statistician may also participate in non-clinical activities including but not limited to Discovery, Translational Research, Product Development. Depending on interest, Director-level will take additional responsibilities of building collaborations in non-clinical areas of Research and Development or other areas outside of clinical development.
• Manages and mentors FTE and Contractor biostatisticians including consulting biostatisticians and interns as appropriate. With at least one direct report.
• Director-level is expected to further drive collaborations with Medical Affairs and Market Access including adoption of cutting-edge statistical methods such as Bayesian statistics, meta-analyses, matching methodologies.
• External presence as evidenced by presentations, publications in Clinical Development and/or other areas of R&D

Qualifications

What you will bring to the role

• Ph.D. in Biostatistics or Statistics preferred, and at least 7 years of experience (10 years for Director) or MS in the same fields with at least 10 years of experience (12 years for Director) in the pharmaceutical industry ophthalmic pharmaceutical industry experience preferred
• Thorough knowledge of statistics as it applies to clinical trials
• Excellent verbal, written, organizational and presentation skills in English. Japanese or Chinese language skills would be an advantage.
• Excellent knowledge of FDA and EMEA statistical guidelines. Submission experience including NDAs/MAAs is strongly preferred
• Demonstrated proficiency in SAS and R
• Ability to become an expert in new therapeutic areas, develop an in-depth knowledge of the disease and treatments that are available or in development, and ability to apply this knowledge to drug development
• Solid understanding of mathematical and statistical principles, including knowledge of methods for handling missing data, longitudinal data analysis, categorical data analysis, multiple comparisons and multiple endpoints, interim analyses, simulation techniques, adaptive designs.
• Knowledge and experience in AI/ML applied to pharmaceutical industry, including imaging, preferred.

Additional Information

What we offer:

The salary range for the Associate Director position is $163,120 – $244,680 depending on experience.
The salary range for the Director position is $195,440 – $293,160 depending on experience.

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.

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