Principal Statistical Programmer

Principal Statistical Programmer

Currently recruiting for a Principal Statistical Programmer to work for a Global biometric CRO who works with the worlds’ leading biotech, pharma and medical device organisations. The role is permanent and will be fully remote working.

They pride themselves on their ability to deliver life-saving medicines to the market as quickly and as safely as possible. Their company values mirror what they look for in employees; quality, respect, honesty, transparency, trust and care.

Overview

1. Multi-discipline role, with focus on delivering:

• Project leadership of assigned complex/multiple projects and/or
• Technical oversight in support of Operations deliveries, projects, initiatives, and training development of Programming personnel.

1. Lead process improvement and knowledge-sharing within the function.
2. Provide advanced project and technical support in the preparation and review of high-quality programming deliverables and documentation, as well as the processes and standards required, to both colleagues and clients.
3. Input to the development of the Programming function and its staff, including encouraging and supporting commercial awareness.
4. Provide high quality, timely support that conforms to current company or client-specific standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.

Responsibilities

1. Deliver outstanding customer care in support of genuine value and a great customer experience.
2. Comprehensive knowledge of clinical and pharmaceutical drug development and associated ICH/GCP guidelines.
3. Comprehensive knowledge of pharmaceutical industry standards.
4. Comprehensive understanding of current company and client-specific standard operating procedures (SOPs) and processes, as well as applicable regulatory requirements and/or guidelines on behalf of the client.
5. Ensure adherence to all relevant SOPs, guidelines and processes.
6. Maintain up-to-date knowledge of the external regulatory environment relating to programming, including ICH/GCP requirements, and provide advice and educate colleagues (and clients) on changes to regulatory requirements and/or other guidelines relating to programming.
7. Provide high quality deliverables and appropriate communication within expected timelines and budget.
8. Use acquired in-depth knowledge and broad expertise to create, update and enhance procedures and applicable SOPs within Programming.

Project Management Ability

1. Comprehensive knowledge of regulatory agency guidelines.
2. Ability to plan resource requirements and project timelines, and recognise project training needs, including multiple/complex projects.
3. Pro-actively address changing timelines, risks, priorities and resourcing requirements in line with appropriate issue escalation processes.
4. Ability to establish and enforce the appropriate standards for multiple projects.
5. Ability to monitor project progress.

Requirements

• Qualified to degree level or equivalent, preferably in a numerate discipline.
• Knowledge and experience on pharmaceutical industry and requirements for delivery of clinical trials.
• Preferably have programming experience covering activities from study set-up to final reporting
• Should have PC skills, good knowledge of statistical software packages (particularly SAS), good organisational skills, good communication skills (oral and written), excellent analytical skills, works well as part of a team, and has a continuous improvement mentality and a good attention to detail.

To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.