Senior Statistical Programmer

Essential

• Deliver best value and high-quality service.
• Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming Coordinator will:
• 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.
• Interact with Sponsors as the key contact with regard to statistical programming issues.
• Provide technical support and advice to the internal team.
• Check own work in an ongoing way to ensure first-time quality.
• Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
• Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup. Sas, formats, Sas, etc.), tracking spreadsheets, and required documentation.
• Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.
• Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.
• Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department.
• Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units.
• Create standard macros and applications to improve the efficiency of the department.
• Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
• Be trained in sponsor WSOPs and disseminate knowledge to project team members as appropriate.
• Proactively participate in and/or lead process/quality improvement initiatives.
• Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.
• Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.
• Maintain and expand local and international regulatory knowledge within the clinical industry.
• Assist project teams in the resolution of problems encountered in the conduct of their daily work
• Provide relevant training and mentorship to staff and project teams.
• Lead and supervise and/or create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.
• Develop mapping specifications for data exports in accordance with applicable standards.

Skills

• Proficiency in SAS.
• Knowledge of the programming and reporting process.
• Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
• Demonstrate ability to learn new systems and function in an evolving technical environment.
• Strong leadership ability.
• Attention to detail.
• Ability to successfully work together with a (virtual) team (including international teams as required) as well as independently.
• Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
• Business/Operational skills that include customer focus, commitment to quality management and problem solving.
• Good business awareness/business development skills (including financial awareness).
• Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
• Work effectively in a quality-focused environment.
• Demonstrate commitment to refine quality processes.
• Effective time management in order to meet daily metrics or team objectives.
• Shows commitment to and performs consistently high-quality work.

Education

• Educated to degree level in a relevant discipline and/or equivalent work experience.

Language Skills

• Competent in written and oral English.
• Excellent communication skills.

Minimum Work Experience

• Relevant Clinical Trial industry experience.