Associate Director, Statistical Programming

Company Name: EyePoint

Be Seen and Heard at EyePoint Pharmaceuticals

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

Responsibilities

Primary responsibilities include, but are not limited to, the following:

Individual 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

Qualifications

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

• 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

Level of Education Required:

• Bachelor's or Master's degree in Statistics, Computer Science, or related field

Number of Years of Experience in the Function and in the Industry:

• 8+ years statistical programming experience with Master’s degree or 10+ years statistical programming experience with bachelor’s degree

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

Transformational Innovation

We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity.

The target salary range for this position is listed below.

Min USD $183,000.00/Yr.

Max USD $224,000.00/Yr.