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Head of Statistical Programming

3 months ago

City of London, United Kingdom Proclinical Staffing Full time
Position Overview

Proclinical Staffing is in search of a Head of Statistical Programming with a strong emphasis on Strategic Management. This position is dedicated to leveraging statistical programming methodologies, crafting effective workflows, and pioneering innovative solutions while ensuring adherence to standard operating procedures (SOPs) and departmental quality benchmarks. The ideal candidate will engage with diverse teams to achieve project objectives and timelines for statistical data evaluation and reporting.

Key Responsibilities:

  • Collaborate with the Senior Director of Statistical Programming to execute global strategies concerning vendor management, technological advancements, automation, processes, and standards.
  • Design effective workflows, innovative solutions, and standards to guarantee timely and high-quality outputs.
  • Ensure adherence to SOPs and both departmental and corporate standards.
  • Lead the creation and execution of a global programming standard library.
  • Develop tools for the efficient generation and validation of derived datasets and TLFs.
  • Provide expert guidance in the establishment and implementation of a centralized clinical data repository, clinical data dictionary, and operational data dictionary.
  • Work in conjunction with Biostatistics to formulate suitable statistical applications.
  • Engage cross-functionally with teams from Clinical Development, Clinical Operations, Regulatory Affairs, and other departments.
  • Guide and collaborate with internal Global Biometric Sciences (GBS) project leaders and contract research organization (CRO) personnel.
  • Identify and assess programming metrics for departmental performance and process enhancement.
  • Participate in ongoing improvement initiatives and process reengineering efforts.

Essential Skills and Qualifications:

  • Bachelor's degree in Statistics, Mathematics, Computer Science, or a related field.
  • Demonstrated experience in the pharmaceutical industry or a clinical research environment.
  • In-depth knowledge of statistical programming.
  • Familiarity with FDA, EMA, ICH, and global regulations and guidelines.
  • Proficient in industry standards relevant to clinical study data and reporting on clinical trials, including CDISC standards.
  • Understanding of the drug development lifecycle.
  • Expertise in the requirements and technology necessary for electronic submissions.
  • Strong project management capabilities.
  • Excellent interpersonal skills along with outstanding written and verbal communication abilities.
  • Capacity to thrive in a fast-paced and dynamic work environment.
  • Robust analytical and problem-solving skills.

Proclinical Staffing is a premier life sciences recruitment agency dedicated to connecting exceptional talent with outstanding opportunities across the globe. Proclinical Staffing operates as an Employment Agency in relation to this position.