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Opportunity: Associate Director, Biostatistics -- Early Development (#1403969) @ Bristol-Myers Squibb -- Princeton, NJ (US)
Submitted by Jody Aikawa; posted on Tuesday, August 19, 2014
RESPONSIBILITIES
The Associate Director, Biostatistics will provide statistical leadership for clinical development programs in phases 1-2.
Responsibilities include:
- Statistical collaboration in clinical program & study design, biomarker & clinical pharmacology strategy, methodology, data analysis & interpretation.
- Author statistical analysis plans, create analysis & dataset specifications, perform statistical analyses, create innovative data displays, author clinical study reports, present & interpret results to clinicians and scientists.
- Perform exploratory & ad-hoc analyses & contribute to publications.
- Continually develop statistical skills and use novel statistical methodology when appropriate.
- Develop & advise other team members.
REQUIREMENTS
- PhD in (bio)statistics, statistical genetics or scientific field with strong statistical theory and methods.
- Minimum of 5 years experience working with clinical trials in the pharmaceutical industry.
- Strong collaboration and leadership skills.
- Ability to adapt to evolving biological knowledge with creativity & rigor.
- Skilled in analysis of pharmacokinetic, pharmacodynamic , safety, efficacy & biomarker data, with an understanding of multiplicity issues; high-throughput genetic & genomic data a plus.
- Experience with standard and advanced statistical methods.
- Expertise in SAS required, S-Plus or R preferred, including advanced statistical analysis, data manipulation, graphing & good software design.
- Strong understanding of regulatory requirements & clinical trial design.
- Demonstrated knowledge of and ability to learn biomarker biology and incorporate biology into analysis & interpretation.
- Ability to work as part of a highly skilled team.
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