Associate Director, Biostatistics at EyePoint Pharmaceuticals, Inc.

, , United States -

Full Time

Start Date

Immediate

Expiry Date

04 Jan, 26

Salary

219820.0

Posted On

06 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Statistical Methods, Clinical Study Design, Regulatory Submissions, SAS, R, CDISC, SDTM, ADaM, Team Leadership, Data Management, Statistical Programming, Collaboration, Innovation, Ophthalmology, Efficacy Analysis, Safety Analysis

Industry

Biotechnology Research

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 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. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual Responsibilities Serves as a project statistician and ensures that the study designs are scientifically sound, and the efficacy and safety information meet regulatory requirements Ensures consistency in data collections, derived data definitions, analysis dataset structure, statistical analyses, and result interpretations throughout drug development 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 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 Supports statistical activities for clinical development programs and provides statistical expertise in the assigned projects 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 Supports statistical activities for the New Drug Application submission to the FDA, the Marketing Authorisation Application to the EMA, and submissions to other regulatory agencies Provides statistical support for internal decision making and external scientific presentations Provides statistical support for 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 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 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 6 years, if PhD, of relevant experience in the pharmaceutical or biotechnology industry; a minimum of 9 years, if MS Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by 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. EyePoint 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. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below. #LI-Remote Min USD $179,445.00/Yr. Max USD $219,820.00/Yr.

Responsibilities

The Associate Director, Biostatistics serves as a project statistician, ensuring scientifically sound study designs and compliance with regulatory requirements. They guide project teams and CRO biostatisticians, ensuring high-quality deliverables and statistical support throughout clinical development programs.