Lead Statistical Programmer

4 weeks ago

Sheffield, Sheffield, United Kingdom Parexel Full time

Aligning our values unlocks limitless potential.

The Principal Statistical Programmer will serve as a recognized authority, offering technical assistance and expert guidance to both internal and external stakeholders. This role operates independently to facilitate various programming tasks associated with the analysis and reporting of clinical trial data. Additionally, the Principal Statistical Programmer may assume the role of Statistical Programming Lead on projects, collaborating with sponsors, Biostatistics Leads, Data Management Leads, and other relevant departments as necessary. Furthermore, this position involves overseeing quality, timelines, resource distribution, and productivity in relation to budgetary constraints.

Required Knowledge and Experience:

  • Proficient in both written and spoken English.
  • Exceptional communication abilities.
  • Demonstrated success in leading teams within a clinical statistical programming context (minimum 5 years experience).

Essential Skills:

  • Strong analytical capabilities.
  • Advanced project management proficiency.
  • In-depth knowledge of SAS programming methodologies (including STDM, ADaM, CDISC), etc.
  • Comprehensive understanding of the programming and reporting lifecycle.
  • Familiarity with SOPs/Guidelines, ICH-GCP, and other relevant local and international regulations such as 21 CFR Part 11.
  • Insight into efficacy endpoints and analysis methods pertinent to the specific disease being addressed.
  • Capability to adapt to new systems and thrive in a dynamic technical landscape.
  • Strong organizational abilities, adept at managing competing priorities, and flexibility to adapt to change.
  • Meticulous attention to detail.
  • Proven ability to lead and mentor a global team effectively.
  • Ability to work efficiently in a quality-driven environment.
  • Excellent time management skills to meet daily objectives or team goals.
  • Commitment to consistently delivering high-quality work.
  • Strong operational skills, including customer focus, dedication to quality management, and problem-solving abilities.
  • Commitment to enhancing quality processes.
  • Effective presentation skills.
  • Negotiation and influence skills to achieve desired outcomes.
  • Good business acumen, including financial awareness.
  • Client-centric approach to work.
  • Proficient negotiation skills.

Educational Background:

  • Degree in a relevant field or equivalent professional experience.

Key Responsibilities:

Project Management:

  • Ability to assume the Statistical Programming Lead role on projects.
  • Contribute to and negotiate statistical programming timelines, ensuring adherence.
    - Coordinate and guide a statistical programming team to successfully complete studies within specified timelines and budgets.
    - Monitor project resources, budgets, and identify scope changes.
  • Oversee project initiation activities, creation of global programs, tracking documents, and other necessary paperwork.
  • Review statistical analysis plans and mock-shells.
  • Evaluate database setup specifications.
  • Provide leadership, project-specific training, stakeholder management, external sponsor support, resource management, and project oversight for programming tasks supporting clinical trial activities.
  • Engage with sponsors and internal stakeholders regarding statistical programming matters.
  • Assist project teams in resolving challenges encountered in their daily operations.

Statistical Programming for Assigned Projects:

  • Deliver optimal value and high-quality service.
  • Continuously verify own work to ensure first-time quality.
  • Employ efficient programming techniques to produce/QC derived datasets (e.g., SDTM, ADaM), tables, figures, and data listings.
  • Generate/QC dataset specifications and other supporting documents and submission materials.
  • Ensure quality control (QC) is executed on all processes and technical activities related to derived datasets, table, data listing, and figure programming in compliance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements.

Training and Development:

  • Maintain and enhance local and international regulatory knowledge within the clinical sector.
  • Expand knowledge of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, and procedures within other Parexel functional areas.
  • Provide relevant training and mentorship to staff and project teams.
  • Lead knowledge-sharing forums and actively support the development of the broader department.

General Responsibilities:

  • Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.
  • Ensure adherence to SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as necessary.
  • Actively engage in and/or lead process and quality improvement initiatives.
  • Provide consultancy to internal and external sponsors regarding statistical programming tasks.
  • Represent Parexel at sponsor marketing and technical meetings.
  • Assess technology and processes to facilitate best practices and enhance quality, efficiency, and productivity.
  • Represent Statistical Programming in cross-functional technical initiatives.
  • Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, and electronic submissions).

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