Senior Statistician - UK/EU

---

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 Senior Statistician to join our Biometrics department remotely in the UK or EU.

You will provide programming and statistical 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 closely with the SAS programming team and communicates Statistical Analysis Plan (SAP), derivations needed and sponsor requests and will be responsible for ensuring the highest quality of every statistical deliverable.

*Key Accountabilities:*

* Provides Statistical consultancy and advice on study design to Sponsor and Project Team.
* Produces sample size calculation for the requirements of the study.
* Provides the randomisation of patients participating in study.
* Writes and reviews protocol for statistics section, SAP and/or statistical content of the CSR.
* Communication with SAS programming team to provide information relating to the study, explain the SAP.
* Acts as statistical point of contact for allocated studies.
* Work closely with Head of statistics and communicate any information related to study life and anticipating troubles.
* Produces and QCs datasets, tables, figures and listings using SAS, including routine statistical analyses.
* Performs ad hoc programming tasks to assist the Head of Statistics with data review.
* Liaises with Data Management to ensure accurate derivation of statistical output from CRF data.
* Communicates database and programming issues to internal and external study teams and suggests resolutions.
* Manages the flow of work for allocated studies to ensure that the scope of work is adhered to, to meet the budget and timelines for all study-related activity.

* Minimum Requirements: *

* Essential: *

* Master's degree Qualified in Statistics 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.

* Desirable: *

* Leading and/or managing a stat and/or SAS programming team
* Experience of Study design and set up
* Experience of Study reporting and CSR production
* Experience across Phase 1/II/III clinical trials
* Awareness of global regulatory environment
* Experience of a wide breadth of therapeutic areas
* Experience interacting with regulatory bodies
* Knowledge of CDISC standards

* Senior Statistician .pdf
*

* 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. *