ABOUT US

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 Senior Statistical Programmer to join our Biometrics Department where you will provide programming and statistical support to allocated studies and will be responsible for ensuring that the clinical trial data is reliable and accurate. You will work closely with the Lead Statistician, SAS Programming Study Statistician and will communicate programming related study issues. You will contribute towards technical leadership within the SAS programming team, ensuring clinical trials are conducted such that subjects’ rights, safety and well-being are protected and is completed within the agreed project timelines.

KEY ACCOUNTABILITIES

• Produces and QCs datasets, tables, figures and listings using SAS, including routine statistical analysis.
• Liaises with Data Management and statistician to ensure the data needed for statistical output from CRF data is available.
• 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.
• Acts as the Statistical Programming point of contact for allocated studies and supports at Sponsor meetings.
• 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 update 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.
• Performs ad hoc programming tasks to assist the Head of Statistics with data review.

SKILLS REQUIRED

ESSENTIAL

• Previous experience as a Statistical Programmer within the pharmaceutical industry or within a Clinical Research Organisation
• Significant SAS programming experience
• Experience of working in multi-disciplinary teams
• Comprehensive knowledge of the Clinical Development process and its critical paths.

DESIRABLE

• Master’s Degree Qualified in Statistics or overseas equivalent
• Previous experience of leading or managing a SAS Programming Team
• Experience of Statistical Programming across Phase 1/II/III Clinical Trials
• Awareness of Global regulatory environment.
• Experience of a wide breadth of therapeutic areas.
• Knowledge of CDISC standards
• Experience in define-XML production and FDA documentation requirement

WHY YOU SHOULD JOIN US

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.