Statistical Programmer - UK

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Job description

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.

*Summary of the Position:*

We are looking for a Statistical Programmer to join our Biometrics department on a remote basis in the UK.

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, Statistical Programming Study Team and will communicate programming related study issues. You will ensure that clinical trials are conducted such that subjects' rights, safety and well-being are protected and are completed within the agreed project timelines to deliver high-quality datasets and TFL deliverables to sponsors.

*Key Accountabilities:*

* Produces and QCs datasets, tables, figures and listings using SAS, including routine statistical analysis.
* 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.
* Provides solutions to issues that arise during the conduct and analysis of the study.
* Supports 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.
* Provides technical support and mentoring for colleagues.
* Performs ad hoc programming tasks to assist with data review.

* Minimum Requirements: *

* Essential: *

* Bachelors Degree or equivalent in Mathematics or related discipline
* 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
* Experience of Statistical Programming across Phase I/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

* Simbec-Orion Job Profile - Statistical Programmer.docx
*

* Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. *