Offer summary

Qualifications:

PhD or MSc in Biostatistics, 3+ years Lead Statistician experience, Excellent understanding of statistical principles, SAS programming experience, Knowledge of regulatory requirements.

Key responsabilities:

Lead statistician role across multiple studies

Oversee project planning and delivery

Develop necessary biostatistics documentation

Execute complex statistical analysis

Support training and development of team members

Job description

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.

Were looking for a Senior Statistician to join our growing Biostatistics team, where youll 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.

This role is home based and therefore we require you to have a set up at home that allows you to work comfortably. This includes an appropriate desk and chair (excl. IT equipment which we will provide).

Responsibilities

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

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.

OPPORTUNITIES:

Mentoring Junior Statisticians
Presenting at Statistical Conferences
Continuous development of skills is encouraged
Well defined career progression plan.

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https://lifelancer.com/jobs/view/2004008da358f7833f10bac957924afa

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