Associate Statistician - UK/EU

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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 an Associate Statistician to join our Biometrics department. You will be based remotely in the UK or EU.

You will provide statistical and programming support to allocated studies within agreed project timelines and ensures 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 as part of the study team under the guidance of the Lead Statistician and closely with the SAS programming team. The Associate Statistician will be responsible for providing statistical support of the highest quality according to strict timelines and works under the supervision of the Statistics Team Lead.

* Key Accountabilities: *

* Provide high-quality statistical support to clinical projects.
* Provide statistical input into the planning and development of clinical study protocols under the guidance of the lead statistician.
* Produce sample size calculation for the requirements of the study.
* Produce the study randomisation code when required.
* Act as an unblinded statistician for a study when required.
* Write and review statistical analysis plans (including design of the table, figure and listings shells) in liaison with the study team.
* Produce and QC datasets, tables, figures and listings, including statistical analyses, using SAS.
* Perform review/provide input into the statistical content of the CSR under the guidance of the lead statistician.
* Be familiar with and work to all the relevant Standard Operating Procedures in force.
* Conduct all studies to the standards of Good Clinical Practice (GCP).

* Minimum Requirements: *

*Essential:*

* Bachelor's or Master's Degree in Statistics, Mathematics or a related discipline or overseas equivalent
* Good communication and organisational skills
* Strong problem-solving skills
* Excellent attention to detail

*Desirable:*

* Previous experience as a statistician within the pharmaceutical industry or a Clinical Research Organisation
* SAS programming experience
* Experience of working in multi-disciplinary teams
* Knowledge of the clinical development process and its critical paths
* Experience across Phase 1/II/III clinical trials
* Knowledge of CDISC standards

Simbec-Orion Job Profile - Associate Statistician.pdf

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* 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. *