Sector: Life Sciences
Consultant: Chris Hutchinson
Salary: £43900 - £70300
Job Status: Permanent / Full Time
My client is a multinational clinical research organization with offices in Ireland, Italy and Switzerland.
It specialises in the biostatistical, data management and methodological areas of health
research, working in the translational space between basic research, clinical and
health-related science and practices.
The company is a young, thriving and exciting environment where statistics,
mathematics, medicine, data science, pharmaceutical science, bioengineering
and computing co-exist and merge at all levels of applied research.
The company focuses its expertise in enhancing the quality of the data and the effective delivery of results in a broad range of therapeutic areas from proof
of concept to global clinical trials, in the pharmaceutical, diagnostics and medical devices industry, clinical therapy, health care and the food industry.
My clinet has a broad range of clients, including large pharma, international medical device and diagnostics firms and multinational food companies, from Europe, North America and worldwide.
The company is expanding its Biostatistics Department in the Dublin office (Ireland) and it is opening a new position as Senior Biostatistician.
The Role and Responsibilities:
- As senior biostatistician, you will work with the Director of Biostatistics to manage the relevant statistical activities of clinical trials. In particular, your responsibilities will include to:
- Manage, provide direction and support an international team of biostatisticians and programmers.
- Support and approve the drafting of the statistical sections of study protocols – including study design and sample size calculations – statistical analysis plans, programming of data files and outputs,
- Provide input in drafting proposals, developing schedules, distributing the workload to the team and project managing.
- Coordinate and be responsible for the submission of deliverables to clients from multiple studies.
- Explain and defend the biostatistical output generated by the team at meetings with other internal teams and with clients as required.
- Train and mentor junior members of the team and subsequently perform quality assurance checks on their work.
- Develop and implement a QC/QA process for the biostatistical deliverables/tasks/outputs as necessary, to ensure that the department meets the quality requirements of its clients with respect to the
- biostatistical work, company policies and procedures and other external standards.
- Support the Director of Biostatistics in Business Development.
This position is for a highly motivated, hard-working and very professional senior biostatistician who can work closely not only with other biostatisticians and
programmers, but also with personnel from data management, medical writing and clinical operations.
Under the supervision of the Director of Biostatistics, you will work on clinical trials phase 1-4 and pre-clinical studies in a variety of
therapeutic areas, within a wide breath of analytical data, globally.
The position impacts on all aspects of the operations.
You will have the opportunity to contribute to the shaping of the future of our vibrant
biostatistics department and its successes.
Skills, Abilities and Experience required:
- A PhD in biostatistics or statistics or equivalent.
- A Master’s degree with strong methodological expertise will also be considered.
- At least 3-4 years of experience in managing, analysing, and reporting the statistical outputs of clinical trials.
- At least 2 years of experience in managing a team of biostatisticians and/or programmers in the pharmaceutical industry or a Clinical Research Organization.
- Strong knowledge of GCP and ICH guidelines and CDASH/CDISC data standards.
- Exceptional communication (written and verbal) skills and proven ability to communicate technical information to both technical and non-technical
- Strong management and organizational skills to reflect experience with staff management, the organization of complex projects and the implementation of project management software packages.
- Knowledge of the English language as mother-tongue, both verbally and written.
- Proven ability to exercise a refined level of attention to details to monitor and improve the quality of the worked carried out.
- Proficient in a variety of software packages including R and SAS.
If you are interested in this please get in touch and send your CV, we are looking to interview candidates as soon as possible.