Offer summary

Qualifications:

Bachelor’s or Master’s Degree in Statistics or Mathematics or a related discipline., Previous experience as a statistician in the pharmaceutical industry or a Clinical Research Organisation., SAS programming experience is essential., Comprehensive knowledge of the clinical development process and CDISC standards..

Key responsabilities:

Provide programming and statistical support to allocated studies within project timelines.

Advise on study design and produce sample size calculations for studies.

Communicate with the SAS programming team and act as the statistical point of contact for studies.

Produce and QC datasets, tables, figures, and listings using SAS, ensuring high-quality statistical deliverables.

Job description

Our Mission

Our passion for improving patients’ lives motivates us to apply our skills, experience and knowledge to advance medicine.

We achieve this through flexible, innovative, high-quality solutions for our clients, delivered with integrity.

The Role

We are looking for a Statistician to join our Biometrics Department where you will provide programming and statistical support to allocated studies within agreed project timelines and 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 communicate Statistical Analysis Plan (SAP), derivations needed and sponsor requests. You will be responsible for ensuring the highest quality of every statistical deliverable according to strict timelines and 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.

About Us

Simbec-Orion is a responsive and agile full-service CRO, delivering studies from first in man through to Phase III. Our experts leverage wide therapeutic experience and specialist expertise to execute a comprehensive portfolio of trials. We are perfectly structured to 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 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.

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