Associate Director, Biostatistics

EyePoint Pharmaceuticals, Inc.

85d • $179,445 - $219,820

About The Position

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, and transforming ocular drug delivery. 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.

Requirements

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

Nice To Haves

• PhD is preferred.
• A minimum of 6 years of relevant experience in the pharmaceutical or biotechnology industry if PhD; a minimum of 9 years if MS.

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.

Benefits

• Competitive salary range of USD $179,445.00 to $219,820.00 per year.
• Robust total rewards package.

What This Job Offers

• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees