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 Statistical Programmer to join our Biometrics department. You will be based remotely in the UK or EU.

You will provide programming support to allocated studies and will support the Lead Statistical Programmer, Lead Statistician, and the Statistical Programming study team. You will communicate programming related study issues to the Statistical Programming study team and ensure clinical trials are conducted such that subjects’ rights, safety and well-being are protected. You will support the study team to ensure that Statistical Programming related tasks are completed within the agreed project timelines to deliver high-quality datasets and TFL deliverables to sponsors.

Key Accountabilities:

• Produces and QCs datasets, tables, figures and listings using SAS, including routine statistical analysis.
• Manages the flow of work for allocated studies to ensure the scope of work, budget and timelines for all study-related activities are adhered to and flags potential changes in scope, database and programming issues to internal and external study teams and suggests resolutions.
• Provides solutions to issues that arise during the conduct and analysis of the study.
• Maintains knowledge of relevant regulatory guidance and requirements.
• Performs ad hoc programming tasks to assist with data review.

Minimum Requirements:

Essential:

• Bachelors Degree or equivalent in Mathematics or related discipline
• Previous SAS programming experience/knowledge
• Comprehensive knowledge of the Clinical Development process and its critical paths.

Desirable:

• Master’s Degree Qualified in Statistics or overseas equivalent
• Previous experience as a Statistical Programmer within the pharmaceutical industry or within a Clinical Research Organisation
• Experience in working in multi-disciplinary teams
• Experience of Statistical Programming across Phase 1/II/III Clinical Trials
• Awareness of the Global regulatory environment.
• Experience in a wide breadth of therapeutic areas.
• Knowledge of CDISC standards

Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on the 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.