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.
- 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 email@example.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.