Dear Allstat,
A Happy Wednesday and I hope your week is going well!
We are currently recruiting for Senior Biostatisticians to join our international programming team to lead or help drive one or more clinical studies, across a variety of therapeutic areas in our FSP division at Cytel:
* Senior Biostatistician
* Permanent / Contract
* Home based in Europe or office based in Geneva / Basel
* Competitive salary + benefits / daily rate
* A great company to work for / work - life balance
How you will contribute:
* provide input into the study design, efficacy and safety parameters and the planned statistical analyses
* perform the sample size calculations
* help prepare / review clinical study reports, and provide input on interpretation of results and integrated summaries for submissions
* respond to requests for the randomization schedule
* review data management related documents and evaluate the quality of the database
* author or review Statistical Analysis Plans (SAPs)
* coordinate with other biostatisticians and statistical programmers to prepare the statistical analyses
* participate in data review/evaluation meetings and other study-related meetings and activities
* contribute and review abstracts, posters, presentations and manuscripts for publication and ensure accuracy of all biostatistical aspects of such documents
What you offer:
* Master's degree in statistics or a related discipline. PhD strongly desired
* 5-7 years in supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired
* Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions
* Knowledge and implementation of advanced statistical methods
* Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus
* Strong knowledge of ICH guidelines
* Solid understanding & implementation of CDISC requirement for regulatory submissions
* Adept in ADaM specifications generation and QC of datasets
* Submissions experience
* Experience working with cross-functional teams, a Study Management Team (SMT) or similar teams for different clients
* Effective communicator: able to explain methodology and consequences of decisions in lay terms
* Team player; willingness to go the extra distance to get results, meet deadlines etc.
* Ability to be flexible when priorities change and deal with ambiguity
Meaningful Work, Collaborative Culture, Stimulating Challenges
* Our collaborative working environment encourages innovation and rewards results, and we are proud to have one of the lowest turnover rates in the industry
* In addition to a competitive salary, we offer an excellent benefits package, annual bonus incentive, promote work-life balance, and the opportunity to grow with us!
* Work with respected experts and thought leaders in the fields of biostatistics and statistical programming
For more information with regards to this opportunity, please contact me directly on +44 1444242220 or email me via [log in to unmask]<mailto:[log in to unmask]>.
I look forward to hearing from you.
Best wishes,
Anetta Kotynska
Recruiter
T: +44 1444242220
M: +44 7597592826
www.cytel.com<http://www.cytel.com>
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