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Who Are You?

An experienced open-source platform developer specializing in building open-source platforms and maintaining libraries for the client.

Position Overview:

We are seeking a highly skilled and motivated developer with experience in open-source platform development and a strong understanding of statistical programming within a biotech or pharmaceutical environment. The ideal candidate will contribute to the maintenance of critical software libraries, support graphics development in R, and help generate Tables, Listings, and Figures (TLFs) using SAS. Familiarity with GxP standards for regulatory submissions is essential.

+ Develop and maintain open-source software platforms with a focus on usability, stability, and scalability.

+ Manage package lifecycles, including dependency resolution, version control, and documentation.

+ Create high-quality visualizations and graphics using R for scientific and clinical data reporting.

+ Ability to work with regulatory-compliant TLFs using SAS, ensuring accuracy and alignment with submission requirements.

+ Ensure all processes and code adhere to GxP and other regulatory guidelines.

+ Contribute to the assessment, deployment, and maintenance of technology solutions that will enable client’s open-source strategy. Solutions include, but are not limited to, package management and containerized development environments.

+ Collaborate with cross-functional teams, including biostatistics, statistical programming, and clinical operations.

+ Attend in-office meetings twice a month in the NJ/NY area.

Required Qualifications:

+ Minimum 8 years of programming experience with at least 3 years of hands-on experience building and maintaining open-source platforms.

+ Strong background in software library maintenance and package management.

+ Proficiency in base R and R Shiny.

+ Experience in generating TLFs using SAS in a regulated environment.

+ Solid understanding of GxP and related compliance requirements for clinical data submission.

+ Excellent communication and collaboration skills.

+ Based in the NJ/NY area with the ability to work on-site twice monthly.

+ Being adaptable and flexible when priorities change.

Preferred Qualifications:

+ Educated to PhD/Masters or Bachelor’s degree in computer science, biomedical engineering, mathematics, data science or a related discipline

+ Background in the biotech, pharmaceutical, or life sciences industry.

+ Contribution to open-source projects using R or active participation in open-source communities.

+ Familiarity with CDISC standards and regulatory submission processes (e.g., FDA, EMA).

+ Experience with containerized development environments (e.g., Docker) and modern DevOps practices.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.