Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.
With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives. THE ROLE
We are looking for a Principal Statistical Progammer to join our Biometrics Department where you will provide support to the Head of Statistical Programming by providing oversite on clinical studies, ensuring standards are maintained according to Simbec-Orion (and/or Sponsor) Standard Operating Procedures (SOPs) ICH-GCP guidelines to ensure the quality of the clinical data delivered to our sponsors is of the highest standard such that subjects’ rights, safety and well-being are protected and is completed within the agreed project timelines. You will provide programming and technical support, training and mentoring to the Statistical Programming team.
A key part of the role will be building and maintaining effective working relationships with a range of stakeholders and assisting with process improvement activities for the department. You will also participate in internal /external audits, system validation activities and presenting at face to face meetings, including Investigator Meetings, Kick-off Meetings and Bid Defence Meetings. KEY ACCOUNTABILITIES
- Manages the flow of work for allocated studies to ensure the scope of work, budget and timelines for all study-related activities are adhered to and flags potential changes in scope, database and programming issues to internal and external study teams and suggests resolutions.
- Produces and QCs datasets, tables, figures and listings using SAS, including routine statistical analysis.
- Acts as the Statistical Programming point of contact for both internal and external customers for allocated studies.
- Attends study team meetings throughout the life of the study to communicate issues that may affect the study.
- Provides solutions to issues that arise during the conduct and analysis of the study.
- Leads on process improvement initiatives within Statistical Programming and plays a key role in reviewing and updating SOPs.
- Maintains knowledge of relevant regulatory guidance and requirements, i.e. GCP, MHRA, CDISC etc.
- Provides in-house training, technical support and mentoring for colleagues.
- Provides support to Business Development and attends bid defence meetings acting as the Statistical Programming expert.
- Minimum A levels (or equivalent)
- Significant experience as a Statistical Programmer within the pharmaceutical industry or within a Clinical Research Organisation
- Knowledge of and experience with CDISC standards
- Experience in define-XML production and FDA documentation requirement
- Experience in working in multi-disciplinary teams
- Experience in training and mentoring colleagues
- Excellent written and verbal communication skills in Fluent English
- Excellent organisation and time management skills
- Excellent attention to detail
- Comprehensive knowledge of the Clinical Development process and its critical paths.
WHY YOU SHOULD JOIN US
- Master’s Degree Qualified in Statistics or overseas equivalent
- Previous experience of leading or managing a Statistical Programming Team
- Experience of Statistical Programming across Phase 1/II/III Clinical Trials
- Awareness of Global regulatory environment.
- Experience in a wide breadth of therapeutic areas.
- An understanding of clinical trial budgets
- Experience in Bid Defence Meetings, including preparatory and follow up meetings
- Experience in managing process improvement activities
Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.
We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.
With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you. our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.