Senior Director, Biostatistics

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.

 

This position reports to the VP, 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

• Provide technical leadership and statistical expertise in the design and execution of late-stage ophthalmology clinical trials
• Contribute to protocol development, ensuring trial design, sample size, and statistical methodologies are appropriate and efficient
• Lead the development of statistical analysis plans, data presentation plans, clinical development plans, biometrics related submission activities, and post-submission strategies/responses
• Review clinical data for accuracy, perform statistical analyses, interpret study results, and collaborate with cross functional teams to produce interim and final reports, as well as publications
• Write/review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and other regulatory processes
• Review vendor data transfer specifications, SDTM and ADaM programming specifications
• Lead assessment and introduction of novel statistical methodologies to implement solutions
• Represent biostatistics function or biometrics department in cross function teams
• Work with department leader to develop and implement department policies, standards and procedures
• Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan
• Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables and budgets
• Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success
• Attend meetings with FDA or other health authorities to ensure ongoing agreement on project development
• All other duties as assigned

Qualifications

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

• Extensive biopharmaceutical industry experience required.
• Deep understanding of clinical trial processes (NDAs/MAAs) and statistical programming requirements for regulatory submissions
• Experience providing statistical support for Medical Affairs and Market Access activities
• Experience interacting with health authorities
• Technical expertise in statistical methodology and strong programming skills with SAS or R
• Excellent written and verbal communication skills and organizational skills
• Good working knowledge of ICH, FDA and GCP regulations and guidelines
• Attention to detail, accuracy and confidentiality
• Critical thinking, problem-solving abilities, and capacity to work independently
• Must be able to effectively multi-task, manage time-sensitive and highly confidential documents, and prioritize conflicting demands
• Comfortable working in a fast-paced, demanding and collaborative environment

Level of Education Required: Ph.D. in Statistics, Biostatistics or a related field with 12+ years or MS degree in a related discipline with extensive industry and leadership experience (15+ years) will also be considered.

 

Preferred Field of Study: Statistics, Biostatistics

Number of Years of Experience in the Function and in the Industry: 12 plus years depending upon degree. Extensive biopharmaceutical industry experience required.

 

Envision Your Future

 

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness