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Job Details

Statistician

Permanent

Posted: 22 hours ago

Description:

* 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 JOB*

We are looking for a Statistician to join our Biometrics department. You will be based remotely in the UK.

You will provide programming and statistical support to allocated studies within agreed project timelines and you will ensure clinical trials are conducted such that subjects' rights, safety and well-being are protected and that the clinical trial data is reliable and accurate. You will work closely with the SAS programming team and you will communicate Statistical Analysis Plan (SAP), derivations needed and sponsor requests. The Statistician will be responsible for ensuring the highest quality of every statistical deliverable according to strict timelines and will work under the supervision of the Head of Statistics.

*KEY ACCOUNTABILITIES*

* Provides advice on study design to Sponsor and Project Team
* Produces sample size calculation for the requirements of the study.
* Provides the randomisation plan and study randomisation code when required.
* Writes and reviews protocol for statistics section, SAP and/or statistical content of the CSR.
* Communicates with SAS programming team to provide information relating to the study.
* Acts as statistical point of contact for allocated studies
* Works closely with line manager and communicate any information related to the study cycle and anticipating issues
* Produces and QCs datasets, tables, figures and listings using SAS, including routine statistical analyses.
* Liaises with Data Management to ensure accurate derivation of statistical output from CRF data.

*SKILLS REQUIRED*

*Essential:*

* Bachelor's or Master's Degree in Statistics or Mathematics (with a substantial statistical component) or a related discipline or overseas equivalent
* Previous experience as a statistician within the pharmaceutical industry or within a Clinical Research Organisation
* SAS programming experience
* Experience of influencing and working in multi-disciplinary teams
* Comprehensive knowledge of the clinical development process and its critical paths.
* Experience of Study design and set up
* Knowledge of CDISC standards

*Desirable:*

* Bachelor's or Master's Degree in Statistics
* Experience of Study reporting and CSR production
* Experience across Phase 1/II/III/IV clinical trials
* Experience of different therapeutic areas.

* 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.

Simbec-Orion Job Profile - Statistician.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. *

Job Details

1593360166
Mon, 09 May 2022 19:00:00 EST
Not Specified, United Kingdom
Permanent