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 your project, helping you achieve your clinical and commercial objectives. Because our goal is the same as yours; to improve patients' lives.

Main Duties and Responsibilities:

We are looking for a Senior Statistical Programmer to join our Biometrics department. You will be based remotely in Hungary.

You will p rovide programming and statistical support to allocated studies and will be responsible for ensuring that the clinical trial data is reliable and accurate. You will work closely with the Lead Statistician, SAS Programming Study Statistician and will communicate programming related study issues.

You will contribute towards the technical leadership within the SAS programming team, ensuring clinical trials are conducted such that subjects' rights, safety and well-being are protected and is completed within the agreed project timelines.

Minimum Requirements:

Essential:

• Previous experience as a Statistical Programmer within the pharmaceutical industry or within a Clinical Research Organisation
• Significant SAS programming experience
• Experience of working in multi-disciplinary teams
• Comprehensive knowledge of the Clinical Development process and its critical paths.

Desirable:

• Master's Degree Qualified in Statistics or overseas equivalent
• Previous experience of leading or managing a SAS Programming Team
• Experience of Statistical Programming across Phase 1/II/III Clinical Trials
• Awareness of Global regulatory environment.
• Experience of a wide breadth of therapeutic areas.
• Knowledge of CDISC standards
• Experience in define-XML production and FDA documentation requirement

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.