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.

We are in search of top talent to help us meet our aggressive and important goals.

ABOUT THE POSITION:

This position will work with the head of Biostatistics in the development, maintenance, and management of biostatistics functions to support clinical development projects managed by Santen Ltd. The job requirements of this position includes providing strategic input to development programs including filing strategies worldwide, study design, analytic methods, endpoints that meet both regulatory and scientific requirements. Dependent upon program size might manage and mentor a team of biostatisticians. 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. 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, Regulatory Agency meetings, medical and statistical meeting.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

• Provide leadership and long-term vision to the biostatistics group to enable the company to meet its regulatory, scientific and business objectives.
• Work with the Biostatistics Head 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
• Work with Biostatistics Head and Human Resources to identify and justify resource needs, develop staffing plans, recruiting process within Biostatistics to hire managers and individual contributors
• Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program

QUALIFICATIONS:

Core competencies, education, and experience:

• 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
• Excellent oral and written communication skills
• Excellent knowledge of FDA and EMEA statistical guidelines. Submission experience including NDAs./MAAs 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 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

WORK ENVIRONMENT AND ENVIRONMENTAL CONDITIONS:

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.