Senior Statistician

at  MAC Clinical Research

MAC is a full-service, global Contract Research Organisation (CRO) providing site and patient services with complete solutions covering a wide range of therapeutic areas.
We’re looking for a Senior Statistician to join our growing Biostatistics team, where you’ll collaborate with experts across disciplines, ensuring high-quality deliverables that contribute meaningfully to human health. You will be joining a company that puts the needs and wellbeing of their people first, who are inclusive and who deliver exceptional service – together.
This is a fully remote working position based in the UK.

KEY REQUIREMENTS:

• PhD or MSc in Biostatistics or related discipline
• 3+ years of prior Lead Statistician experience at a CRO, biotech or pharmaceutical company
• Excellent knowledge and understanding of the statistical principles, concepts, methods and standards used in clinical research.
• A developed understanding and experience of SAS programming language.
• Extensive knowledge of regulatory requirements for clinical trials.
• Excellent oral and written communication skills with the ability to present complex methodology and data to non-Statisticians.
• Proven experience of delivering successful outcomes across client, vendor and internal teams.
• A strong understanding of PK analysis techniques and their application in clinical studies. Preferably with experience using Phoenix WinNonlin.

Perform the Lead Statistician role across multiple studies and clients. Delivering high quality outputs according to MAC processes, ICH-GCP, the study budget and timelines to achieve high client satisfaction.

Perform or oversee:

• Advanced project oversight, planning and delivery from a Statistical perspective, collaborating with MAC Clinical and Biometrics teams.
• Development of Biostatistics documentation, including Statistical Analysis Plan (SAP), Randomisation Specifications and Statistical Reports.
• Input into Protocol, Clinical Study Report (CSR), Study Design and Sample Size Calculations as required.
• Planning and executing complex statistical analysis including analysis of pharmacokinetic data.
• Participate in bid defence and study kick-off meetings with new and prospective clients.
• Lead ongoing department quality process and system improvements.
• Support ongoing training and development of Statistics team members