What are the responsibilities and job description for the Associate Director, Statistical Programming position at Ocular Therapeutix, Inc.?
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
The Associate Director, Statistical Programming will be the Lead Statistical Programmer on multiple clinical trials in the Statistical Programming function, including NDA and other submissions to regulatory agencies.
Principal Duties And Responsibilities Include The Following
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.
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
The Associate Director, Statistical Programming will be the Lead Statistical Programmer on multiple clinical trials in the Statistical Programming function, including NDA and other submissions to regulatory agencies.
Principal Duties And Responsibilities Include The Following
- Serve as trial lead programmer to produce and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses
- Write specifications to describe programming needs.
- In collaboration with biostatisticians and other clinical development colleagues. develop/review TFL shells, SDTM and ADaM specifications
- Work closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate.
- Partner with or oversee CROs or Programming vendors to perform the tasks defined in the contract.
- Review CRF pages and ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements.
- Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
- Master's Degree in statistics, mathematics, computer science, or related scientific/medical field.
- 8 years of (SAS) statistical programming experience in a clinical trial setting (industry/CRO).
- Advanced SAS programming skills - reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC
- In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of their implementation in clinical trials.
- Experience with outsourcing programming activities and overseeing services provided by CROs and contractors.
- Advanced knowledge of programming standards and processes.
- Ophthalmology experience is preferred.
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.
Salary : $185,000 - $198,000
