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Director Statistical Programming - Strategic Oversight
- Permanent
- Programming
- United Kingdom
This vacancy has now expired. Please see similar roles below...
Proclinical is seeking a Director of Statistical Programming Specialist with a focus on Strategic Oversight. This role focuses on applying statistical programming strategies, developing efficient processes and innovative solutions and ensuring compliance with SOPs and departmental quality levels. The successful candidate will also collaborate with various teams to meet project deliverables and timelines for statistical data analysis and reporting.
Responsibilities:
- Work alongside the Sr. Director of Statistical Programming to implement global strategies related to vendor oversight, technology innovation, automation, processes, and standards.
- Develop efficient processes, innovative solutions, and standards to ensure timely and quality deliverables.
- Ensure compliance with SOPs and departmental and corporate standards.
- Lead the development and implementation of a global programming standard library.
- Develop tools for efficient production and verification of derived datasets and TLFs.
- Provide functional expertise in the development and implementation of a centralized clinical data repository, clinical data dictionary, and operational data dictionary.
- Collaborate with Biostatistics to develop appropriate statistical applications.
- Collaborate cross-functionally with teams from Clinical Development, Clinical Operations, Regulatory Affairs, and others.
- Guide and collaborate with internal Global Biometric Sciences (GBS) project leads and CRO staff.
- Identify and evaluate programming metrics for department performance and process improvement.
- Participate in continuous improvement activity and process reengineering.
Key Skills and Requirements:
- Bachelor's degree in Statistics, Mathematics, Computer Science or related discipline.
- Proven working history in a pharmaceutical industry or another clinical research setting.
- Deep understanding in statistical programming.
- Good knowledge on FDA, EMA, ICH, and global regulations and guidelines.
- Proficiency in industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards.
- Comprehension of the drug development process.
- Expertise in the requirements and technology to support electronic submissions.
- Strong project management skills.
- Strong interpersonal skills and exceptional written and oral communication skills.
- Ability to work in a fast-paced and dynamic environment.
- Strong analytical and problem-solving skills.
If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan on h.hennigan@proclinical.com.
Apply Now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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