ProClinical is advertising a vacancy for a Biostatistics Manager with a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. This organisation, which prides itself on its international reach, is seeking for the Biostatistics Manager to join their team in the UK.
The Biostatistics Manager will be ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically correct. They will influence study design, defend statistical approaches both internally and externally, and ensure strict adherence to company policies, SOPs, and other controlled documents.
- Providing statistical contributions, statistical review, and quality control of Key Design Elements (KDE) protocols, randomisation specifications, Statistical Analysis Plans (SAPs), Table, Listing, and Graph (TLG) shells, Submission Data (SDF) specifications, protocol deviations, Flash Memos, Clinical Study Reports (CSRs), clinical publications, other key study related documentation, and other communications.
- Completing statistical analysis of individual studies/projects.
- Publishing applied research in scientific journals and books and giving presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings).
- Communicating the role of the Global Biostatistics department and contributing to statistical training within Global Biostatistics and the company.
- Assisting in the review of company policies, SOPs, and other controlled documents.
- Assisting with study and systems audits conducted by the company CQA and external bodies.
- Serving as a team member in change/process improvement initiatives.
- Maintaining familiarity with statistical policy and strategy with the company.
- Staying abreast of the latest developments in the field of statistics in drug development and contributing to scientific advances in the field.
Skills and Requirements:
- A degree in Statistics/Biostatistics, or a subject with a highly statistical content.
- Demonstrable experience with Lifecycle drug development experiences, including pre-clinical, clinical development, and post-marketing.
- Demonstrable experience in designing, analysing, and reporting clinical trials.
- Proven history with at least 1 study with minimal oversight.
- Experienced with authoring protocols, DRT/DCM, SAP or CSR.
- Experienced with project planning.
- An ability to learn, assimilate, and effectively communicate information to support colleagues, discuss with partners, and advise clients on requirements.
- Strong interpersonal skills, including communication, leadership, relationship management, and influencing.
- Capable of leading interdisciplinary projects and to implement change within a high-performing organisation.
- Demonstrable computer software skills, including MS Office.
- A flexible mindset that is suited to dealing with multiple projects in a timely manner.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Harry Williams on +44 203 854 0102 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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