Senior Principal Biostatistician

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

This role is part of Alcon's Research & Development function, a team that innovates boldly and delivers new products and services to help revolutionize the eye care industry, advance optimal patient outcomes and help people see brilliantly.

The Sr. Principal, Biostatistics (Science/Tech/Engineering Path) is primarily responsible for supporting project teams in product development strategies and managing clinical and non-clinical studies. You will lead scientific development, ensure quality deliverables, and collaborate with statistical programmers.

In this role, a typical day will include:

• Provide scientific and technical leadership and management of multiple projects in one or more therapeutic areas in biostatistics across multiple projects, ensuring robust statistical methodologies support product development strategies, regulatory submissions, and post-marketing activities

• Lead the development of clinical and non-clinical study designs, statistical analysis plans, and data interpretation to determine safety, efficacy, and marketability

• Must exhibit ability to independently assist in creation of development plans and lead scientific development of all related protocols for multiple projects.

• Independently lead all efforts related to project-level activities, to include all analyses and inputs into regulatory filings for all phases of development as well as medical affairs activities, including support for publication and conference presentations.

• Manage complex statistical challenges across therapeutic areas, guiding teams through all phases of clinical development, including regulatory interactions and submissions

• Oversee statistical programming efforts, ensuring quality, timeliness, and efficiency in deliverables while providing mentorship and strategic guidance to programmers and statisticians

• Develop and optimize business and technical processes related to statistical systems and data management, formulating operational specifications and integrating innovative data solutions

• Lead system development initiatives, coordinating project execution, testing, training, change management, and system upgrades

• Act as a key liaison between business and technology teams, defining statistical and data processing requirements to enhance operational efficiencies

• Partner with cross-functional teams to ensure statistical strategies align with broader business and regulatory objectives, proactively identifying risks and implementing mitigation plans to drive success

• Ensure and manage quality, timeliness, and efficiency for all support and deliverables for designated projects.

• Liaise with and provide needed guidance to statistical programmers assigned in support of project and trial deliverables.

• Include the accountabilities of statisticians assigned to projects.

• Establish and maintain working relationships with project-specific functional representation.

Experience:

• The ideal candidate will hold a PhD in statistics or biostatistics and have at least five years of experience in the pharmaceutical, biotechnology, or CRO industry with a proven record in the design and analysis of clinical trials or a Master's degree in statistics or biostatistics with at least ten years of experience.

• Proficiency in statistical programming with SAS and/or R is required.

• Possess hands-on expertise in mixed models for repeated measures (MMRM), multiple-imputation techniques for missing data under varied assumptions, and a solid working knowledge of the ICH E9(R1) estimand framework, including strategies for managing intercurrent events.

• Familiarity with ADaM standards, particularly defining and implementing ADICE datasets to support estimand-aligned analyses, is desirable.

• Experience preparing Statistical Analysis Plans (SAPs), contributing to regulatory submissions (e.g., FDA, EMA), and interpreting relevant regulatory guidance is a strong plus.

• Must be able to explain complex statistical concepts clearly and collaborate effectively with clinical, programming, data-management, and regulatory teams.

• Complete understanding and wide application of statistical principles, theories, and concepts in the field.

• Resident expert and Biostatistics go-to person for projects.

• Independently determines and develops approaches to solutions as issues arise on project.  Proposed solutions are imaginative, thorough, practicable, and consistent with organization and project objectives.

• Completed work is reviewed in terms of meeting the organization’s objectives and schedules.

• Quality and timeliness of all deliverables for projects.

• Compliance with internal and external standards as measured by audit findings.

• Sound knowledge of project therapeutic areas and relevance to study design.

• Good knowledge of product development and commercialization process and relevant guidelines and processes.

• Emerging Health Authority expertise.

• Excellent written and oral communication.

What You'll Bring to Alcon:

•        Bachelor’s Degree or Equivalent years of directly related experience (or high school+15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)

•        The ability to fluently read, write, understand and communicate in English

•        7 Years of Relevant Experience

How You Can Thrive at Alcon:

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

• Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more!

• Travel Requirements: 0-5%

• Relocation assistance: Yes

• Sponsorship available: Yes   

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Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.