Senior Biostatistician
Pleiad Devices, Perth, UK
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As a result of ongoing expansion, we are seeking a Senior Biostatistician
for this new, permanent post within our organisation. Flexible or part
time working may be considered. The role will be based in Pleiad’s
Corporate Headquarters in Perth, UK; travel throughout the USA and EU will
be required from time to time as well as occasional trips to Canada. The
role reports to the COO.
The Role
i. To provide or manage the provision of the following
biostatistics services to Pleiad clients:
· Preparation of statistical methodology sections for clinical
study protocols
· Preparation of statistical analysis plans for the analysis of
clinical studies
· Performance of statistical analyses of data and interpreting
results to ensure validity of conclusions
· Interaction with Data Management personnel (internal and
external) as necessary to ensure that datasets are in usable format
· Perform statistical diagnostics prior to database lock
· Ensure that appropriate programmes are developed for clinical
studies
· Performing statistical quality control review and program
validation for each project
· Interacting with Medical Writers in production of statistical
and integrated clinical/statistical reports and other documents containing
statistical information
· Reviewing clinical study protocols, statistical analysis plans
and other documents as required
· Act as the biostatistics contact for clients within Pleiad
· Contribute to the production of systematic literature reviews
ii. To manage the organic growth of the Biostatistics Services
department as dictated by increases in workload. This includes assisting
in the employment of high quality staff and managing contract staff as
appropriate.
iii. To provide ad hoc advice and support to the Pleiad Business
Development group in terms of interactions with potential clients.
Qualifications, Skills and Experience
· M.S. degree in Statistics
· Demonstrate at least 3 years experience in the analysis of
clinical data
· Previous experience of working within the biopharmaceutical
industry would be preferred
· Experience of working with medical devices will be a distinct
advantage
· Proficient in the use of SAS
· Able to read, analyse and interpret common scientific journals
and technical journals
· Good understanding of clinical research, device/drug
development, good clinical practices and good clinical research practices
and statistical methods
· Competent word processing (Word), spreadsheet (Excel) and
presentation (Powerpoint) skills
· Excellent spoken and written English
· Excellent interpersonal skills with the ability to communicate
effectively with scientific and non-scientific groups; strong
organizational skills with strong attention to detail
· Strong sense of responsibility, urgency and integrity and
ability to work flexibly to meet changing scopes and timelines
· Ability to work without close supervision and to coordinate
the activities of other staff
Applications
Please submit your CV, along with a covering letter, to:
Jennifer Trueland, Administration & Services Manager, Pleaid Devices, The
Balmoral Suite, Royal British House, Leonard Street, Perth, PH2 8HA (or by
email to [log in to unmask])
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