Director, Statistical Programming

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 Director, Statistical Programming is a player-coach role and will be responsible for leading statistical activities in support of clinical trials and 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. The Director will also develop processes, provide input into the ongoing monitoring of randomization, and other key functions.

Responsibilities:

• Identify, implement, and support process improvements and standard procedures within the Statistical Programming Group.
• Lead, mentor, and manage the Statistical Programming team.
• Drive innovation within the department by identifying and implementing new technologies and best practices.
• Act as technical consultant to other departments.
• Develop and maintain relationships with external partners, vendors, and stakeholders.
• 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.
• Create programs that generate kit and randomization lists when appropriate.
• Ensure the integrity of the randomization process within the IRT system.
• 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).
• Provide leadership, expertise, and guidance across delivery teams as required.
• Oversee the recruitment, training, and evaluation of the department.
• Perform other duties as required and assigned.

Education:

• Masters of Science in Statistics, Computer Science, Mathematics, Engineering, Life Sciences, or related subject area is highly preferred.
• Bachelor's in Computer Science, Engineering, or similar fields is required.

Experience:

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

Skills:

• Extremely strong attention to detail with excellent organizational skills and proven ability to multi-task.
• Excellent time management skills, and 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.

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