VP, Biometrics

Overview

Be Seen and Heard at EyePoint Pharmaceuticals

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

We See You.

Your wellbeing

Your professional worth

Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

We are seeking a Vice President, Head of Biometrics and will be responsible for creating and implementing both the near-term and long-term strategic direction for EyePoint clinical program. This includes all areas and phases of development while ensuring systems, capabilities, and resources are in place to optimize the design/ conduct and analysis/interpretation of clinical trials and clinical data, respectively. This person will report to the Chief Medical Officer.

This position is fully remote.

This person should have a positive attitude and be adaptable to a dynamic startup environment.

Responsibilities

Primary responsibilities include, but are not limited to, the following:

Individual responsibilities

• Serve as the strategic partner working closely with other relevant functions in providing statistical input into strategy, design and execution of clinical development plans and trial designs

• Provide expert statistical input/review/Q.C. to ensure proper statistical methods are applied, data quality meets or exceed industry and company standards, and data interpretation is accurate internally (e.g., clinical studies, programs, regulatory submissions, publications) and externally (e.g., response to health authorities, questions from collaborators/alliance partners, presentations to advisory panels, and to address business needs)
• Provide leadership to team of internal FTE’s, external contractors, and vendors accountable for statistics and statistical programming, including managing performance, developing people, hiring and integrating new team members and fostering EyePoint’s values, mission, and culture
• Serve as the point of escalation to ensure the timeliness and accuracy of biometric deliverables
• Collaborate with partner functions to provide statistical programming, systems analysis and database management support for important Clinical Development, Operations, Safety, Medical Affairs deliverables (e.g., risk-based monitoring, signal-detection and validation by pharmacovigilance, potential application of machine learning to important clinical deliverables)
• Serve as the biometrics subject matter expert for the company; capable of representing the company both internally and externally (e.g., present analyses to regulatory agencies, investigators, and collaborations, lead development and adaptation of new statistical methodology in support of clinical development)
• Lead and/or author development of new procedures and process improvement (e.g., development of statistical standards such as SAPs, outputs; data sharing procedures for internal and external audiences; data QC prior to release) to meet the needs of an evolving Biometrics Department
• Oversee biostatistical activities outsourced to CROs including review and check of biostatistical and programming related SOPs

Qualifications

Primary skills and knowledge required include, but are not limited to the following:

• Ophthalmology experience highly desired, experience in retina is a plus
• Experience interacting with FDA, EMA and other health authorities, including regulatory submission (e.g. NDA/BLA) is required
• Extensive knowledge of Health Authority requirements (e.g., GCP, ICH, 21 CFR Part 11, EMA/CHMP regulations, CDISC standards)
• Extensive experience in using statistical techniques including general linear models, predictive modeling, mixed effects models, multivariate analysis, etc
• Demonstrable experience in using data-science methodologies including clustering, classification, machine learning, etc.
• Strong programming skills in SAS required, R programming experience preferred
• Strong data visualization skills
• Knowledge and previous experience in integrating data from relevant databases is a plus
• Self-motivated- able to work autonomously and must thrive on challenge
• Ability to anticipate challenges and devise strategies for success
• Result and deadline-oriented
• Excellent presentation and communication skills

Level of Education Required:

• Advanced degree (e.g., MS, PhD) in Statistics, Biostatistics, or related field preferred

Number of Years of Experience in the Function and in the Industry:

• 10+ years of biometrics experience across academia and the pharmaceutical/biotech industry
• At least 5 years of management experience leading a team of biostatisticians and statistical programmers. Experience managing data management team is a plus

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed topreventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

• Success begins with our People
• Patients First
• Integrity
• Results-Driven
• Innovation
• Team Focus
• Diversity & Inclusion

EyePoint Pharmaceuticals is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.