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Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.
Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.
Position Summary:
About the Company
Ocular Therapeutics is an innovative biotechnology company dedicated to developing transformative therapies for patients with serious diseases. Our current focus includes advancing treatments in ophthalmology, with a strong emphasis on retinal disorders.
Position Summary
We are seeking an experienced Contractor Biostatistician to provide statistical expertise and operational support for our late-stage clinical development programs. The successful candidate will support Phase 3 clinical studies and contribute to Real-World Evidence (RWE) initiatives.
Principal Duties and Responsibilities include the following:
- Provide statistical input into the design, analysis, and interpretation of Phase 3 clinical trials.
- Collaborate with cross-functional teams (clinical, data management, programming, medical writing) to ensure statistical deliverables meet project timelines and quality standards.
- Contribute to the development of statistical analysis plans (SAPs), table/figure/listing (TFL) shells, and statistical programming specifications.
- Review and interpret clinical trial data, generating summary reports for internal decision-making and regulatory submissions.
- Support Real-World Evidence studies, including study design, methodology, and statistical analyses.
- Review protocols, CRFs, and other study documents to ensure statistical integrity and regulatory compliance.
- Collaborate with external vendors/CROs to oversee statistical programming and analyses.
- Participate in responses to regulatory agency queries and prepare statistical sections for submission documents.
Qualification Requirements:
- Master’s or Ph.D. in Biostatistics, Statistics, or related discipline.
- Minimum 7 years of experience as a biostatistician in the pharmaceutical or biotech industry with a PhD degree or minimum of 10 years experience with a master degree.
- Strong knowledge of statistical methodologies such as survival models, mixed models etc.
- Demonstrated expertise in Phase 3 clinical trial design, conduct, and analysis.
- Strong knowledge of ICH guidelines, CDISC standards (SDTM, ADaM), and regulatory submission requirements.
- Experience with Real-World Evidence (RWE) studies preferred.
- Prior work in retinal diseases or ophthalmology preferred.
- Proficiency in SAS (required); experience with R is a plus.
- Strong problem-solving, organizational, and communication skills.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.
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