Priya Mukherjee at CK Clinical is currently recruiting for a Director, Biostatistics to join a leading pharmaceutical organisation at their site in the South East.
The purpose of this Director,Biostatistics role is to collaboratively produce and support critical data-based evidence for assertions and label claims about medicines through all Phases (I-IV, NIS, IIT) covering biomarkers, efficacy, safety, PRO/QOL and HEOR HEOR for simple and complicated trial designs and challenging analyses.
As a Director, Biostatistics you will
- Handle the day-to-day operational managerial role of single EU Biostatistics team integrated over UK and Germany delivering a regional tactical focus with strong global liaison on a coordinated joint delivery with other regions – across various therapeutic areas including oncology, cardiovascular and metabolic.
- Through strategic leadership in project teams, you will add value to the company by accelerating worldwide product approvals and enhancing EU product market share and appeal.
- Enhance functional technical expertise in designing, driving and delivering high quality objective core contributions at the heart of the EU drug development and commercialisation process together with the required ‘state-of-the-art’ regional and global infrastructure.
- Lead a regional Biostatistics group who oversees all project related biostatistical activities.
- Develop, directs, prioritises and monitors all statistical programs and processes relevant to clinical trial design, data collection and input, data analysis, data display, QC, and reporting of results with the primary purpose of accelerating worldwide product submissions and investigational product approvals.
- Oversees and monitors project timelines to ensure established corporate target dates are met.
- Encourage, monitor, and facilitate biostatistical activities and interactions between international sites, towards the development and implementation of global statistical analysis and reporting standards.
- Review of all clinical trial protocols, clinical trial reports, and analysis deliverables
- Ensure quality of all deliverables related to data analysis, display, and reporting of clinical trial results.
- Provide close interaction with cross-functional groups in the review and selection of CROs; develops and reviews CRO contracts; tracks CRO milestone, timelines, and issues; resolves same.
- Develop long-range plans for the future of Biostatistics, and monitors metrics and evaluates staff performance. Manages and develops the technical competence and careers of the biostatistical staff.
- Provide leadership to Biostatistics in setting short-term and long-term departmental, project, and professional goals and objectives.
- Create momentum, energy, and opportunities for visibility of group within corporate and functional settings.
- Expand support to new areas and builds new cross-functional relationships while solidifying and enhancing existing relationships.
Qualifications and skills:
The successful application for this Director – Biostatistics job will have the following skills and qualifications:
- A Ph.D in Statistics, Biostatistics or Mathematics (OR Equivalent).
- Proven Pharmaceutical Industry experience, together with proven supervisory/management and project management experience.
- Exposure to vendor risk and performance management, compliance and oversight.
- Good oral and written communication skills.
- Proficient in Microsoft Office Suite including Word, Excel, and Project
- Demonstrated problem solving, analytical, organization, and time management skills
- Excellent managerial skills; coaches, guides, and professionally develops direct reports
- Exhibits customer focus, flexibility and team spirit
- Ability to lead and influence others
- Demonstrated experience in leading remote teams
- Ability to function effectively in different cultural settings
- Proven experience in the implementation of electronic data capture (EDC)
For more information or to apply for this Director – Biostatistics role please contact Priya Mukherjee on 01438 743 047 or email email@example.com. Please quote reference CL24311 in all correspondence.
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