Principal Biostatistician HTA
- Employer
- Proclinical Staffing
- Location
- Bayern, Munich, Germany
- Salary
- Negotiable
- Start date
- 13 May 2021
- Closing date
- 27 May 2021
View more
- Discipline
- Data Management / Statistics, Biostatistics
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
A large pharmaceutical organisation, is looking for a talented Principal Biostatisitician HTA to join their team in Germany. This organisation is dedicated to putting patients at the heart of their journey and bringing about effective change in medicine. Job Responsibilities- Provide input to clinical development plans, protocols, clinical study reports, regulatory submission materials, abstracts and manuscripts to ensure that statistical elements are in line with leading edge knowledge and the overall product strategy
- Define and drive statistical strategy across programs ensuring acceptable statistical methodology to competent authorities and scientific community.
- Inform health economic analysis within HTA Lead the development of the statistical analysis plan for clinical trials
- Provide specifications and directions to the statistical programmers in establishing standards for clinical conduct and data collection, management and/or reporting of data
- Manage and supervise CROs regarding statistical activities to ensure timely delivery of Statistical deliverables and provide guidelines and standards to CROs to ensure quality of deliverables
- Identify, evaluate, and promote the use of innovative statistical methodology within and outside the organisation through scientific collaborations, publications in scientific peer reviewed journals, presentations
- Contribute to interactions with external review boards / ethics committees, external consultants and key opinion leaders
- Master's or doctoral degree in Biostatistics, Statistics, Epidemiology or Mathematics
- Ideally a minimum of five to eight years experience in Pharma, Biotech, CRO or similar sector with previous experience in applying statistical methods in safety-related aspects of biomedical research Expertise in SAS and/or R to perform statistical analysis
- Experience applying Bayesian models in biomedical research
- Familiarity with complex statistical methods that apply to Phase I-IV clinical trials, including adaptive designs
- Ideally more than two years of experience as an HTA statistician and in analysing safety data in clinical trials
- Experience of safety signal detection with appropriate statistical tools, expertise in epidemiologic methods and meta-analyses
Company
At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.
Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives.
ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating.
Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.
- Website
- https://www.proclinical.com/
- Telephone
- 0800 988 4437
- Location
-
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom
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