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Job type: Permanent

Discipline: Statistics, Data Management, Programming

Location: United States

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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