Director, Biostatistics

EyePoint Pharmaceuticals; Watertown (MA); Hybrid; USD 110,000 - 160,000; Full time

Job summary

EyePoint Pharmaceuticals is seeking a Senior Biostatistician to lead statistical activities for clinical development programs. This role involves pivotal responsibilities including statistical submissions and protocol development, contributing significantly to the company's mission of preventing blindness through innovative therapeutics. Candidates should possess a strong background in ICH/EMA/FDA guidelines, with 8+ years in the pharmaceutical or biotechnology field, and a desire to work in a collaborative, inclusive environment.

Qualifications

• Minimum of 8 years of relevant experience in the pharmaceutical industry (if PhD).
• Experience with CDISC, SDTM, and ADaM datasets.
• Ability to innovate in clinical study design.

Responsibilities

• Leads statistical activities for clinical development programs.
• Supports FDA New Drug Application submissions.
• Guides project teams on efficient study design.

Skills

Knowledge of ICH/EMA/FDA guidelines

Statistical methods and applications

Programming skills in SAS

Experience in regulatory interactions

Team leadership

Education

MS or PhD in statistics

PhD preferred

Job description

Overview

Be Seen and Heard at EyePoint

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 ascience-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.

This position reports to the Sr. Director, Biometrics and is located at our Watertown, MA site or may be remote. We offer a hybrid work schedule.

Responsibilities

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

Individual responsibilities

• Leads statistical activities for clinical development programs and provides statistical expertise in the assigned projects
• Supports statistical activities for the New Drug Application submission to the FDA, the Marketing Authorization Application to the EMA, and submissions to other regulatory agencies
• Participates in protocol development and prepares statistical sections in the protocol, Statistical Analysis Plan and Mock Tables, Listings, and Figures for the Clinical Study Reports and Integrated Summary of Safety/Integrated Summary of Efficacy
• Serves as a project statistician and ensures that the study designs are scientifically sound, and the efficacy and safety information meet regulatory requirements
• Guides the project teams in using the most efficient or innovative study design by considering the regulatory agencies’ requirements for the country and regions the compound will be submitted, and help to maximize the success of the drug product
• Ensures consistency in data collections, derived data definitions, analysis dataset structure, statistical analyses, and result interpretations throughout drug development
• Provides statistical support for internal decision making and external scientific presentations
• Provides input to the entire clinical development plan to ensure that the overall strategy can deliver the pre-specified target product profile and that proposed studies have appropriate clinical trial designs
• Researches statistical methodologies for ophthalmology diseases and addresses specific statistical issues in the design of clinical studies for Phase 1 through Phase 4
• Guides CRO biostatistician on assigned projects to ensure consistency in derived data definitions, analysis dataset structure, analysis methodologies, and accuracy of analysis results
• Ensures timely delivery of high-quality deliverables
• Authors documents and responses submitted to health authorities globally
• Works collaboratively with other functions within EyePoint to meet shared objectives

Qualifications

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

• Knowledge of ICH/EMA/FDA guidelines
• Experience in regulatory interactions and submissions (NDA and or BLA experience is preferred)
• Ability to innovate creatively in a clinical study design setting
• Ability to effectively collaborate and influence other functions
• Experience working with Statistical Programming and Data Management functions
• Demonstrated ability to serve effectively as a team leader
• Comprehensive knowledge of statistical methods and applications in study design and analysis
• Programming skills in SAS (required) and R (preferred)
• Experience in implementation of CDISC, SDTM, and ADaM datasets

Level of Education Required:

• MS or PhD in statistics, biostatistics, other related fields with high statistical content
• PhD is preferred

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

A minimum of 8 years, if PhD, of relevant experience in the pharmaceutical or biotechnology industry; a minimum of 11 years, if MS

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology companycommitted topreventing blindnessby developing and commercializing innovative therapeutics.

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

Transformational Innovation

We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

EyePointis proud to bean 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.

#LI-Onsite

#LI-Remote