Associate Director, Statistical Programming

EyePoint Pharmaceuticals, Inc.

140d • $183,000 - $224,000

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. This position is reporting to the Sr. Director, Statistical Programming. This is a remote role.

Requirements

• In-depth knowledge of CDISC SDTM/ADaM standards and FDA electronic data submission requirements
• Advanced knowledge of SAS/Base, SAS/Macro, SAS/STAT, and SAS/Graph. Familiarity with R is a plus.
• NDA or BLA submission experience is required
• Excellent organizational skills and ability to prioritize tasks in a fast-paced, small company setting.
• Excellent communication and interpersonal skills
• Experience managing CROs and other data vendors
• Knowledge of ICH guidelines, Good Clinical Practices, FDA / EMA / other regulatory authority guidance
• Bachelor's or Master's degree in Statistics, Computer Science, or related field
• 8+ years statistical programming experience with Master’s degree or 10+ years statistical programming experience with bachelor’s degree

Responsibilities

• Responsible for providing technical leadership for Statistical Programming activities on assigned studies
• Collaborate closely with Biostatistics, Clinical Data Management, and other stakeholders to provide programming support as needed
• Act as a Programming Subject Matter Expert on assigned studies, including generation or validation of SDTM and ADaM datasets, as well as producing Tables, Figures, and Listings as needed
• Provides programming support for publications, posters, and presentations in a timely and high-quality manner
• Oversee Statistical Programming deliverables provided by service providers
• Contributes to the preparation of regulatory submissions including Evaluating CDISC electronic data packages for completeness, regulatory standards compliance and submission readiness
• Serves as the statistical programming primary point of contact for a given program or across various programs and studies, representing the Statistical Programming function on the clinical team for cross-trial activities as needed
• Develops and manages timelines for statistical programming deliverables, ensuring timely completion of projects as applicable
• Contributes to the development and maintenance of departmental policies, procedures, training, and standards
• Works with IT to develop and maintain programming environment to ensure data security and system integrity

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees