Head of Biostatistics

COMPANY DESCRIPTION

Santen is a specialized pharmaceutical company focused exclusively on ophthalmology in global markets around the world with more than 3,500 employees and sales in approximately 60 countries. Santen Inc., located in Emeryville, CA, contributes important ophthalmic research and development efforts worldwide and is home to our regional business teams. This office currently employs about 140 people and will grow by 50%+ in the near future.

With the passionate support of our Japanese parent company and its 125-year heritage, Santen is pursuing intellectually-challenging and stimulating work to deliver game-changing therapies that make hope a reality for people facing vision impairment and loss.

We are driven by and committed to our mission: Delivering Vision, Every Day. Additionally, our Corporate Strategy Policy for FY18-FY20 has provided essential focus for new commercialization efforts that will be fueled through an unprecedented increase in marketing investment and talent acquisition across Marketing, Sales, and R&D teams.

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

PRIMARY PURPOSE OF POSITION

We are looking for a Head of Biostatistics who will be responsible for the development and management of biostatistics function at Santen Inc to provide statistical leadership in designs, conduct, analysis and result interpretation of clinical studies, and to influence decision making for clinical research and development programs. This person will collaborate closely with Programming and Data Management and leaders in other functional areas including Clinical Science, Clinical Operation, Pharmacovigilance, Regulatory and Project Management, and represent Bio-statistics to interact with external collaborators and thought leaders.

MAJOR DUTIES OF POSITION:

• Provide leadership and long-term vision to the Bio-statistics group to enable the company to meet its regulatory, scientific and business objectives.
• Work with the Head of Global Data Science 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.
• Ensure scientific integrity of the statistical methodology applied to clinical trials.
• Strategically leverage a combination of internal and external resources to adapt for short-term needs while maintaining long-term resourcing plans.

• Clarify project deliverable's and timelines for statistical analysis and reporting.
• Recruit, train, guide career growth, and provide development opportunities for biostatisticians.
• 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 advanced statistical topics.
• Lead the statistical research in clinical trial area.
• Represent Santen as a SME in statistics in all communications, conference calls, and face-to-face meetings with regulatory agencies.
• Provide advice and support as requested for Project Management and Business Development.

KNOWLEDGE AND SKILL REQUIREMENTS:

• Ph.D. in Biostatistics, Statistics or related fields with 10+ years of experience or MS with 12+ 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.
• 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 efforts across departments to ensure organizational effectiveness.
• Ability to use competitive intelligence to influence clinical development.
• Ability to articulate the reasons behind organizational changes and demonstrate resilience throughout change efforts.
• Ability to reach out and collaborate with external expertise.
• Ability to coach and provide feedback.
• Ability to develop in-depth therapeutic area knowledge of the disease and treatments, and apply the knowledge to clinical development programs.

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