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 ROLE
We are looking for a Senior Statistician to join our Biometrics department. 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 will communicate Statistical Analysis Plan (SAP), derivations needed and sponsor requests. The Senior Statistician will be responsible for ensuring the highest quality of every statistical deliverable according to strict timelines and works under the supervision of the Statistics Team Lead or the Head of Statistics. KEY ACCOUNTABILITIES
SKILLS REQUIRED ESSENTIAL
- 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 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, explaining elements of the Protocol/SAP where required.
- 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.
- 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 and flags any potential problems or changes in scope to Line Manager
- Bachelor’s or Master’s Degree in Statistics, 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
- Experience of Study reporting and CSR production
WHY YOU SHOULD JOIN US
- Master’s degree in Statistics or overseas equivalent
- Leading and/or managing a Statistics and/or SAS programming team
- Wide experience across Phase 1/II/III/IV clinical trials
- Awareness of global regulatory environment.
- Experience of a wide breadth of therapeutic areas.
- Experience interacting with regulatory bodies
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.