Manager/Associate Director

This position will work as 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 and statistical input to development programs encompassing 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 other biostatisticians (especially Associate Director role). The candidate will lead company’s statistical analysis activities, such as implementing statistical principles and standards including 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, Medical Affairs etc.), make presentations and represent biostatistics to therapeutic leads, senior management, external collaborators and thought leaders, attend Regulatory Agency meetings, medical and statistical meetings.

Principal Accountabilities:

• 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 (especially Associate Director role).
• 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 methodology research in clinical trial area at Santen (especially Associate Director role)
• 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.
• Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program.
• Implement AI/Machine Learning methods for selected clinical projects
• Depending on interests support selected Translational Research, Non-Clinical, and Pharmaceutical Development with advanced statistical and AI/ML methods

Additional responsibilities for Associate Director level role:

• Provide leadership and long-term vision to the biostatistics group to enable the company to meet its regulatory, scientific and business objectives.
• 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 Biostatistics Lead and Human Resources to identify and justify resource needs, develop staffing plans, recruiting process within Biostatistics to hire managers and individual contributors.

Requirements

• Ph.D. in Biostatistics or Statistics and at least 7 years of experience for Associate Director role or at least 4 years of experience for Manager role in the pharmaceutical industry. Ophthalmic pharmaceutical industry experience preferred.
• Excellent oral and written communication skills.
• Knowledge of FDA and EMEA statistical guidelines. Submission experience including NDAs/MAAs preferred but not required
• 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
• Familiarity and experience with AI/ML techniques as applied to pharmaceutical industry
• Excellent judgment and problem-solving skills in complex situations.
• Excellent negotiation and interpersonal skills
• Demonstrated ability to drive change and influence decision making.
• Demonstrated ability to integrate planning efforts across departments to ensure organizational effectiveness.
• Demonstrated ability to use competitive intelligence to influence clinical development.
• Demonstrated ability to articulate the reason behind organizational changes and demonstrate resilience throughout change efforts
• Demonstrated ability to set up and influence collaborations with external organizations.
• Management style that delegates to & empowers employees and fosters teamwork.
• Demonstrated ability to coach and provide feedback.
• Demonstrated 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.