Director Statistical Programming Oncology

Highly Competitive
  1. Permanent
  2. Programming
  3. United Kingdom
City of London, England
Posting date: 10 Jul 2024
61322

Proclinical is seeking an experienced Statistical Programmer for a Director position. This role is centred around creating strategies for programming, creating efficient processes, and ensuring deliverables meet classifications and timelines. The ideal candidate will have the ability to work alongside other various teams and guide project leads to align with established data, analysis, and quality standards.

Responsibilities:

  • Collaborate with the Senior Director to administer 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 cross-functionally with teams from Clinical Development, Clinical Operations, Regulatory Affairs, and others to meet project deliverables and timelines.
  • Guide and collaborate with internal project leads and CRO staff to ensure alignment with established data, analysis, and quality standards.
  • Identify and evaluate programming metrics to judge department performance and evaluate existing processes and guidelines for continued process improvement.

Key Skills and Requirements:

  • Bachelor's degree in Statistics, Mathematics, Computer Science or an equivalent discipline, an advanced degree is preferred.
  • Proficiency in statistical programming.
  • Solid understanding of FDA, EMA, ICH, and global regulations and guidelines.
  • Solid understanding of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards.
  • Solid understanding of the drug development process from early- to late-stage development and submission.
  • 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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