Contract SAS Programmer (Gene Therapy - Ophthalmology)

** PLEASE NOTE: This is a contract position. We able to offer this at either 50% capacity (~20 hours per week) or 100% capacity (~40 hours per week) **

The Company

AAVantgarde is a clinical-stage, international biotechnology company headquartered in Italy. We have developed two cutting-edge AAV vector platforms to overcome DNA cargo limitations, targeting Usher syndrome type 1B and Stargardt disease. Founded by the renowned Professor Alberto Auricchio, a pioneer in gene therapy, our mission is to transform genetic medicine for patients with no current therapeutic options. Join us at AAVantgarde and be a part of our innovative journey to bring the next generation of genetic medicines to those in need.

The Role

We are seeking a highly experienced and hands-on Principal SAS Programmer to join our team in support of a cutting-edge gene therapy clinical trial program in ophthalmology. This role is crucial for the successful execution of our clinical trials and involves advanced programming, data management, and process optimization. The ideal candidate will have a strong background in SAS programming, CDISC standards, and clinical trial data analysis, with the ability to actively contribute to and lead various process-driven initiatives.

In this role, you will provide expert-level programming support for our gene therapy ophthalmology program, creating and maintaining SAS programs to clean, analyze, and report clinical trial data. Ensuring that all programming and reporting follow CDISC standards, particularly SDTM and ADaM, will be paramount to ensure compliance with regulatory requirements and industry best practices. You will actively contribute to the development and execution of SAS programs to derive analysis datasets, tables, listings, and figures for clinical study reports (CSRs) and regulatory submissions. Collaboration with cross-functional teams, including biostatistics, clinical operations, data management, and regulatory affairs, will be key to driving processes and ensuring the accurate and timely delivery of clinical data.

Leading efforts to ensure data integrity and consistency throughout the clinical trial, you will develop validation checks, data cleaning scripts, and identify and resolve data discrepancies. Your role will also involve providing technical leadership and mentorship to junior programming staff, ensuring knowledge transfer and promoting best practices in SAS programming, CDISC standards, and clinical trial processes. Acting as a change agent, you will streamline programming workflows and improve efficiency, ensuring alignment with company standards and regulatory requirements. Additionally, you will support the preparation of datasets and programming outputs required for regulatory submissions, ensuring that all deliverables meet the highest standards for accuracy, completeness, and consistency.

Skills and Experience Required

The ideal candidate will possess a Bachelor\’s or Master\’s degree in a related field, such as Life Sciences, Computer Science, or Mathematics. You should have a minimum of 8-10 years of experience in SAS programming within the clinical trials environment, with significant experience in gene therapy and ophthalmology clinical trials. Strong expertise in CDISC SDTM and ADaM standards, including the creation, manipulation, and validation of datasets for regulatory submissions, is essential. You should have in-depth experience with clinical trial data management, analysis, and reporting, and extensive hands-on programming experience using SAS (BASE, STAT, MACROS, SQL, etc.).

Proven expertise in SAS programming for clinical trial data analysis and reporting, deep knowledge of CDISC standards, and experience in preparing data for regulatory submission to bodies like the FDA and EMA are crucial. A strong understanding of clinical trial design, with a particular focus on ophthalmology and gene therapy, is also required. You should have the ability to manage complex datasets and lead process-driven initiatives, along with excellent problem-solving skills to identify and resolve issues in data, processes, and timelines. Strong leadership and communication skills, with experience mentoring junior programmers and driving cross-functional collaboration, are essential.

Preferred Qualifications

Preferred qualifications include experience with clinical trial management systems (CTMS) and electronic data capture (EDC) platforms, knowledge of R programming or other statistical tools, and familiarity with regulatory submission processes, such as eCTD, NDA/BLA submissions. Personal attributes that are highly valued include strong leadership abilities, the ability to manage multiple priorities effectively, high attention to detail and a commitment to data quality and compliance, strong initiative with the ability to drive change and process improvement, and the ability to work under pressure and meet tight deadlines in a fast-paced environment.

What\’s in it For You

At AAVantgarde, we believe in creating an environment where our employees can thrive. Our flexible working environment allows you to balance work and life effectively. Our central London office, just a stone\’s throw from London Victoria train station, offers a prime location with top-notch facilities including a gym, coffee shop, and a rooftop garden. As a rapidly growing biotech with recent funding, there are ample opportunities for career advancement, and as we grow, so can you. We offer a generous salary, bonus, pension, health insurance through Vitality, and income protection, ensuring you have the support and resources you need to succeed. Join us and be part of an exciting, innovative journey in the world of biotechnology.

Equal Opportunities

At AAVantgarde, we are committed to fostering a welcoming, collaborative, and inclusive environment. We believe in providing equal opportunities for all and do not discriminate on the basis of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected characteristics. All applicants will receive equal consideration for employment.

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