Director Statistical Programming

Proclinical is currently recruiting for a Director of Statistical Programming with a global biotechnology company located in Boston, MA. As the Statistical Programming Director, you will build the programming platform and lead the programming team to implement global functional strategy.

Job Responsibilities:

• Implementation of global statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency.
• Support the development and implementation of a global programming ecosystem to enable successful project deliverables.
• Participate in the development and implementation of centralized data warehouse.
• Develop department programming standards to meet business needs and regulatory requirements, enabling efficient and seamless production of deliverables.
• Develop innovative solutions to standardize, automate and optimized efficiency and quality.
• Develop tools for efficient verification of derived datasets, e.g. SDTM and ADaM, and TLFs.
• Build a team of programmers to support ongoing pipeline expansion.
• Generate ad hoc data sets and TLFs on ongoing basis.

Skills and Requirements:

• Master's or bachelor's degree in related field.
• 8 years of experience in the pharmaceutical industry and/or CRO.
• Excellent knowledge of statistical programming in SAS including Base, macro, STAT, GRAPH, SQL.
• Solid understanding of FDA, EMA, ICH and global regulations and industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards.
• Expertise in the requirements and technology required to support electronic submissions.
• Experience in leading submissions and managing people.
• Strong leadership and project management skills.

If you are having difficulty in applying or if you have any questions, please contact Felix Hook at (+1) 646-367-2617 or f.hook@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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