Associate Director/Director, Biostatistics at Santen, Inc.

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 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. The statistician will also lead data mining and/or AI/ML of clinical or translational data, incorporation of Real World Data and/or digital data into clinical development, clinical decision-making, and Health Authority interactions for their clinical programs. Director-level 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.

Santen has a hybrid working model, so the statistician is expected to work on-site in Emeryville, CA a portion of each week.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

• Provides strategic input to development programs including filing strategies worldwide, clinical study designs, analytic methods, endpoints that meet both regulatory and scientific requirements
• Coordinates and manages requests for data formatting, analyses and visualization/representation to support all key global projects in Santen portfolio 
• Manages and mentors FTE and Contractor biostatisticians including consulting biostatisticians and interns as appropriate; Director-level will manage direct reports.
• Work closely and effectively with other members of Global Data Science, including Programming and Clinical Data Management
• Lead company’s statistical analysis activities, such as implementing statistical principles and standards such as CDISC standard, supporting clinical projects, developing innovative study designs and leading all the effort to perform state of the art statistical analysis
• Make presentations and represent biostatistics to therapeutic leads, senior management, external collaborators and KOLs, FDA meetings, FDA advisory boards [and other Health Authorities], and medical and statistical meetings 
• Serves as statistical representative in the cross-functional teams for the clinical trial planning, executing, and reporting 
• Guides the Biostatistics team members for all planning activities including modeling and simulation
• Contributes to the development of Protocol by participating in study design meetings, determining appropriate statistical methodology for data analysis (including definition of endpoints, sample size planning and power calculation, specifications of statistical models and testing procedures, etc.), and drafting the statistical sections of Protocol
• Drafts data analysis plan documents such as Statistical Analysis Plan and Centralized Monitoring Plan, incorporates comments from other relevant functions, and finalizes the documents 
• Participates in database design meetings to ensure that the eCRF designs comply with the Protocol and capture all data required to support a quality database and planned analyses
• Specifies an appropriate randomization scheme and reviews pseudo randomization schedule(s)
• Generates mock-up tables, listings, figures (TLFs) for project deliverables as necessary and incorporates comments from other relevant functions to ensure appropriate presentation of analysis results 
• Reviews the SDTM specification document and generates detailed ADaM specification document based on the SDTM specification document 
• Guides Statistical Programming in preparing for the project deliverables, reviews statistical outputs, and participates in validation of statistical outputs as necessary
• Prepares oral and written reports to effectively communicate outcomes of clinical trials to the study team, management, regulatory agencies, key opinion leaders, or individual investigators
• Conducts statistical quality control to ensure the accuracy of analysis results in regulatory documents or publications to be presented in public 
• Collaborates with Clinical Operations, Data Management, and Statistical Programming to perform necessary risk-based statistical monitoring on living database to help improve the site performance and data quality
• Provides statistical support as needed for reports required by the Data Monitoring Committee
• Provides statistical support for other functions such as Pharmacovigilance, Medical Affairs, and Marketing
• Participates in study team meetings and other activities organized to improve operational and statistical analysis procedures
• Attends meetings and participate in conference calls with regulatory agencies or investigators, presents statistical methodologies and/or outputs at meetings, and responds to statistical questions raised by other attendees
• Involves in research for innovative statistical methodologies for clinical trials
• Maintains the version control for statistical documents
• Attends conferences and job-related trainings as appropriate
• Ability to determine when to use internal resources or a CRO experience managing outside consultants/CRO’s preferred 
• Contribute to external statistical community through presentations, publications, and service in cross-industry initiatives
• Lead data mining, AI/ML, and data sciences activities, including incorporation of novel data types, to inform clinical trial design, reverse translation, and clinical development decision-making
• Collaborate with Medical Affairs and Market Access on secondary publications from clinical trials, evidence generation, post-marketing requirements
• 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
• Participates in Due diligence activities as Data Science Member
• Other duties may be assigned as needed.

Qualifications

• 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 
• Excellent knowledge of FDA and EMEA statistical guidelines. Submission experience including NDAs/MAAs is strongly preferred
• 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, and bioinformatics
• Demonstrated proficiency in SAS and R
• Excellent judgment and problem solving skills in complex situations 
• Excellent negotiation and interpersonal skills 
• Ability to drive change and influence decision-making 
• Ability to integrate planning efforts across departments to ensure organizational effectiveness 
• Ability to use competitive intelligence to influence clinical development
• Ability to articulate the reason behind organizational changes and demonstrate resilience throughout change efforts 
• Ability to set up and influence collaborations with external organizations 
• Management style that delegates to and empowers employees, and fosters teamwork 
• Ability to coach and provide timely and constructive feedback
• 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 
• Demonstrated ability to provide insight into patterns within data which sheds new light on optimal ways in which treatments should be used
• Expertise in AI/ML for complex datasets preferred
• Director-level: Demonstrated ability to lead analysis teams for novel and emerging data types with impact

Additional Information

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. 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.

All your information will be kept confidential according to EEO guidelines.

For more information about our company and the work experience, please visit www.santen.com/us.