A specialist contract research organisation (CRO) are looking to hire multiple Principal Programmers to work out of their UK offices. The organisation provides high quality analysis and consultancy of Phase I-IV clinical trials across a variety of therapeutic areas for the pharmaceutical industry. This position offers the exciting opportunity to work with a leading establishment and provider of real expertise in the biometrics field. You would be joining a team that is looking to invest in long term careers, focusing on quality of service, with up to date, relevant industry training.
- Review clinical trial documents including protocols, SAPs, CRFs, and CSRs.
- Author, review, and approve study TFL shells and dataset specifications.
- Author, validate, and document SAS programs for datasets, TFLs, and macros, applying good programming practice.
- Identify data issues and outliers.
- Complete, review, and approve CDISC Validation tool reports,
- Identify data and standards issues and resolve or escalate as appropriate,
- Maintain an awareness of emerging standards and associated impact to ongoing and future planned trials.
- Maintain proficiency in SAS and awareness of developments.
- Maintain study master file documents and any other documents that are required to be audit ready.
- Line manage statisticians, programmers, and other technical staff.
- Accountable for overall performance of direct reports.
- Coach and mentor staff to achieve "excellence". Direct employee career development and ensure line reports receive appropriate training to perform their day-to-day jobs.
- Interview and effectively on-board and integrate new staff members.
- Provide programming technical leadership and coaching.
- Oversee key client projects/portfolios.
- Lead internal and client study, project, and cross functional team meetings effectively.
- Present study updates internally and at client meetings.
- Share scientific, technical, and practical knowledge within the team and with colleagues.
- Perform work in full compliance with applicable internal and client policies, procedures, processes, and training.
- Develop and provide internal technical training where appropriate.
- Lead process improvement initiatives.
Skills and Requirements:
- BSc, MSc, or PhD in numerical discipline (or relevant equivalent industry experience).
- At least 6 years of relevant industry experience.
- Understanding clinical drug development process, relevant disease areas, endpoints, and study designs.
- Awareness of industry and project standards & ICH guidelines.
- Proficiency in data handling using SAS or other statistical software (e.g. R).
- Ability to manage a portfolio of projects and/or people.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emma Adams at +44 203 854 3893 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Rome (province), Italy
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