Principal Statistical Programmer

3 days ago

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Description

• Project Management: Ability to fill Statistical Programming Lead role on projects -Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. • Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget. • Monitor project resourcing, project budgets, and identify changes in scope. • Review statistical analysis plans and mock-shells. Review database set-up specifications. • Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities. • Interact with sponsors and internal stakeholders with regard to statistical programming issues. • Assist project teams in the resolution of problems encountered in the conduct of their daily work. • Deliver best value and high quality service. Check own work in an ongoing way to ensure first-time quality. • Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings. • Produce/QC dataset specifications and other process supporting documents and submission documentation. • Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements. • Maintain and expand local and international regulatory knowledge within the clinical industry. • Develop knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, and processes/procedures within other PAREXEL functional areas. • Provide relevant training and mentorship to staff and project teams. • Lead knowledge sharing forums and proactively support the development of the wider department. • Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. • Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required. • Proactively participate in and/or lead process/quality improvement initiatives. • Provide consultancy to internal and external sponsors with regard to statistical programming tasks. • Represent PAREXEL at sponsor marketing and technical meetings. • Assessment of technology and processes, to facilitate best practices and increase quality, efficiency, and productivity. • Represent Statistical Programming on cross-functional technical initiatives. • Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).

Requirements

• Excellent analytical skills. • Advanced knowledge of SAS programming techniques. • Extensive knowledge and understanding of the programming and reporting process. • Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. • Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated. • Ability to learn new systems and function in an evolving technical environment. • Strong project management skills. • Strong organizational skills, ability to manage competing priorities, and flexibility to change. • Attention to detail. • Ability to successfully lead and mentor a global team. • Work effectively in a quality-focused environment. • Excellent time management in order to meet daily metrics or team objectives. • Show commitment to and perform consistently high quality work. • Strong business/operational skills that include customer focus, commitment to quality management, and problem solving. • Demonstrate commitment to refine quality processes. • Good presentation skills. • Ability to negotiate and influence in order to achieve results. • Good business awareness/business development skills (including financial awareness). • Client-focused approach to work. • Good negotiation skills. • Competent in written and oral English. • Excellent communication skills. • Proven record of successfully leading teams in a statistical programming environment.