Sr. Manager/Associate Director, Biostatistics

COMPANY DESCRIPTION

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 field—through 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. 

ABOUT THE POSITION:

This position will work with the Head of Biostatistics or Lead Statistician in the development, maintenance, and management of biostatistics functions to support clinical development projects managed by Santen. The job requirements of this position include providing strategic input to development programs including filing strategies worldwide, study design, analytic methods, and endpoints that meet both regulatory and scientific requirements. Dependent upon program size and level the candidate might manage and mentor a team of biostatisticians. The candidate will dead company’s statistical analysis activities, such as implementing statistical principles and standards such as CDISC, support clinical projects, develop innovative study designs and lead efforts to perform state of the art statistical analyses. The candidate will collaborate with other functional areas within the company (Statistical Programming, Clinical Data Management, Clinical Development, Global Drug Safety, Regulatory and Project Management, etc.),make presentations and represent biostatistics to therapeutic leads, senior management, external collaborators and thought leaders, attend Regulatory Agency meetings, medical and statistical meetings.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

• Contribute to protocol development by choosing an appropriate study design and statistical methodology, defining end points, calculating necessary sample size to achieve a pre-specified power and writing the statistical section of the protocol 
• Develop and review the Statistical analyses plan
• Support generation and review of tables, listings, figures to ensure accurate and appropriate analysis and results for clinical studies 
• Ensure the quality of data and accuracy of analyses in regulatory submissions (eg, CSR) or publications
• Conduct and participate in validation of project deliverables as necessary
• Perform statistical analysis and prepare corresponding sections of the Clinical Study Report 
• Provide leadership and long-term vision to the biostatistics group to enable the company to meet its regulatory, scientific and business objectives (AD level). 
• Work with the Biostatistics Head and Lead Statistician to develop and monitor the department strategic direction and its alignment with company strategies.
• Provide statistical direction and technical oversight for complex projects requiring statistical input as a Subject Matter Expert (SME) in statistics area. 
• Monitor and understand the impact of industry and company strategies on the Biometrics organization and deliverables.
• Represent Santen as a SME in statistics area in all communications, conference calls and meetings with regulatory agencies.
• Ensure scientific integrity of the statistical methodology applied to clinical trials. 
• Strategically select a combination of internal and external resources to provide for analytic needs, and clarify long-term resourcing plans. 
• Clarify project deliverables and timelines for statistical analysis and reporting, and ensure that they are met. 
• Provide leadership and direction for departmental strategic initiatives.
• Develop and maintain all biostatistics related SOPs and guideline documents
• Support the presentation and publication of clinical trial results and contribution to advances on statistical topics. 
• Lead the statistical research in clinical trial area at Santen
• Participate in Clinical Trial Teams and in activities organized to improve operational and statistical analysis procedures.
• Monitor project progress and ensures proper biostatistics resource allocation for successful project deliverables against goals and timelines 
• Provide advice and support as requested for Project Management and Business Development.
• Supervise and mentor professional staff members, consultants as appropriate.  Develop biostatisticians by assessing and providing appropriate training, setting goals, coaching, and recognizing those who make significant contributions to business objectives (AD level)
• Work with Biostatistics Head and Biostatistics Lead and Human Resources to identify and justify resource needs, develop staffing plans, recruiting process within Biostatistics to hire managers and individual contributors (AD level) 
• Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.

QUALIFICATIONS:

• Ph.D. in Biostatistics or Statistics, and 7+ years of experience or MS in the same fields with 8+ years of experience in the pharmaceutical industry, ophthalmic pharmaceutical industry experience preferred (AD level)
• Excellent oral and written communication skills. 
• Excellent knowledge of FDA and EMEA statistical guidelines. Submission experience including NDAs./MAAs preferred (AD level)
• 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 preferably; knowledge of other statistical software is a plus 
• 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 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.

COVID-19 Vaccination Requirement: Santen requires anyone working on-site or visiting company offices to confirm they are fully vaccinated against COVID-19 unless a medical or religious accommodation is timely requested and approved. 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.

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