Principal Biostatistician

POSITION TITLE: Principal Biostatistician

DEPARTMENT: Biostatistics

Ora Values the Daily Practice of …
Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor
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At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia and Latin America.

The Role:

Apply a high level of technical expertise to help guide and develop the more junior biostatistics staff members. Serve as a lead statistician on clinical studies and provide senior-level peer review of work being accomplished by other biostatisticians. Maintain the statistical and analytical integrity of clinical trials analyzed by Ora. Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies, as required. Support business development and project management with strategic planning, proposals, pricing, and timeline planning.

What You'll Do:

• Serve as an internal consultant for biostatistics analysis tools and methods.
• Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support.
• Actively support business development in capabilities presentations to prospective and current clients.
• Effectively manage assigned clinical study budgets for biostatistics analysis support.
• Develop, coach, and mentor junior Biostatistics Department personnel.
• Act as the lead statistician on clinical research projects and help with SAS programming.
• Provide statistical expertise for study design of clinical trial protocols.
• Write statistical methods section of the study protocol, as needed.
• Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed.
• Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP).
• Program summary tables, data listings and graphical representations of clinical trials data.
• Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data.
• Prepare/review key sections of clinical study reports and various regulatory documents.
• Perform statistical QC of all department outputs, including analyses and clinical study reports.
• Provide statistical support to answer questions from external clients (such as FDA Investigators).
• Contribute to the development, maintenance, and training of standard operating procedures (SOPs).
• Represent the Biostatistics Department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed.
• Manage biostatistics timelines, budgets, and client expectations.
• Adhere to all aspects of Ora's quality systems.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements.
• Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.
• Responsibilities may differ from the above based on the specific needs of the business.

What We Look For:

• Experience needed for the Role:
  • Typically, a master's degree in biostatistics, statistics or other related, scientific field and four (4) years of relevant professional experience; or a PhD in biostatistics, statistics or other related, scientific field and three years of relevant experience; or equivalent combination of experience, education, and/or demonstrated ability.
• Additional Skills and Attributes:
  • Effective leadership; skilled in analytical evaluation, organization, delegation, flexible team and department management, negotiation and resource management, and budgeting and forecasting.
  • Excellent analytical skills, with the ability to process scientific and medical data.
  • Excellent knowledge of statistical programming.
  • Expertise in manipulating and analyzing SAS data.
  • Ability to identify data issues, understand, articulate and present problems clearly, and implement effective and time-efficient solutions in stressful situations.
  • Capability of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues and clients.
  • Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).

• Competencies and Personal Traits:
  • What We Do:
    • Execution Excellence: Ability to set goals, create structure, and maintain a focused and collaborative approach to the delivery of timely and high-quality work, of all types.
  • How We Do It:
    • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again.
    • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth.
  • Why We Do It:
    • Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see.

What We Offer:

• Well-Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1.
• Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays.
• Financial: Competitive salaries along with a 401K plan through Fidelity with company match.
• Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave.
• Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure.
• Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases.
• Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family.
• Career Development Opportunities: Continued opportunities to grow and develop your career journey.
• Global Team: Opportunities to work with colleagues across the globe.
• Impact: A chance to research new ophthalmic therapies that will impact patients across the globe.

Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week.

Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member.

We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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