About Us:

Endpoint is an interactive response technology (IRT®) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE® platform, have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. Endpoint is headquartered in Wakefield, Massachusetts with offices across the United States, Europe, and Asia.

Position Overview: The Statistical Programmer is responsible for statistical activities in support of clinical trials and Interactive Response Technology (IRT) implementation. This includes contributing to trial designs, authoring statistical sections of IRT requirements, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. This role is also responsible for developing processes and providing input into the ongoing monitoring of randomization and other key functions.

Responsibilities:

• Consult with clients on statistical approaches as required.
• Write, modify, and maintain statistical programs and macros that produce randomization files, data sets, tables, and listings for assigned projects.
• Review study protocols and randomization requirements to create and verify randomization and kit lists.
• Ensure the integrity of the randomization process within the IRT system(s).
• Document and manage new and existing randomization lists.
• Develop simulation programs to evaluate dynamic randomization models.
• Review Statistical Analysis Plans and provide feedback to the author(s).
• Perform other duties as required and assigned.

Education:

• Bachelors’ degree in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or related subject area is required.
• Associate level degree with relevant working experience will be considered.

Experience:

• 4+ years of statistical programming experience, preferably in processing clinical trial data.
• Experience in statistical programming languages and software such as SAS, R, and Python required. SAS Certification(s) are highly preferred.
• Prior experience in IRT platforms, eClinical technologies, life sciences, or regulated industries is highly preferred.
• Knowledge of regulatory guidelines such as 21 CFR Part 11 and GxP.

Skills:

• Extremely strong attention to detail with excellent organizational skills and proven ability to multi-task.
• Excellent time management skills with the ability to meet aggressive deadlines.
• Demonstrated leadership and interpersonal skills, and a willingness to lead by example.
• Excellent oral and written communication skills, ability to send and receive clear, concise, and professional communications, both internally and externally.
• Ability to work independently, as well as within teams.
• Solution-orientated, able to find solutions to novel problems

Endpoint Clinical does not accept unsolicited resumes from search firms or any other third parties. Any unsolicited resume sent to Endpoint Clinical will be considered Endpoint Clinical property, and Endpoint Clinical will not pay a fee should it hire the subject of any unsolicited resume.

LI-MT $60,000 — $100,000/year