Director Biostatistics
4 weeks ago
Biostatistics Director
is to act independently as Compound Statistician for complex work in an established area within clinical development. This position may also act as Global Statistical Lead for an early or back up asset or as a Methodology expert validating the execution of complex techniques.
The role can be offered in
#freelance
basis for the right skills and experience.
Responsibilities:
Accountable for leading Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact.nLead or provide the statistical input into the design of the program, protocol input such as study design, sample size calculations and patient randomization schemes and statistical aspects of case report form designnPreparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reportsnWriting of the statistical methods sections of integrated study reports. Reviews draft integrated study reports.nLead or supports responses to regulatory questions on the design of the programnOngoing coaching and mentorship of team members.
Key Requirements:
PhD or M.S in Biostatistics, Statistics or related scientific fieldnSignificant experience in applying statistical methods in Pharma or CRO settingnAdvanced and broad knowledge of statistical methods, along with understanding of industry practices related to the statistical analysis of clinical datanGood ability in SAS required, knowledge of R preferred.nAbility to understand, implement, and explain complex statistical methodology,nSignificant advantage: #oncology or #rarediseases
If this opportunity is of interest, please apply now with your CV at your earliest availability. If further info needed, please feel free to connect with Catalin Zaharia.
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