*Hi, **Hope you are doing great. Please go through the below mentioned
requirement and share the profiles at **a...@tresourceinc.com
*Job Title: Biostatistician with Pharma*
*Location: Irvine, CA*
*Type of hire: 6-12+ months Contract *
*Interview Mode: Telephonic and Skype/F2F*
*Job details: *
· Review and input on all SAPs, key TLFs for studies and ISS/ISE,
CSR to ensure consistency.
· Review of statistical aspects of study publications
· Review and approval of ADaM specifications with the statistical
· Primary quality of efficacy and safety ADaM data sets,
integrated data sets, and TLFs.
· Ensuring timelines are met for deliverables
· Review and input DMC biostatistics activities (SAP, TLFs, input
on DMC Charter).
· Input to presentation of study results to Development team.
· Review and approval with the Statistical programmers of the
e-submission Package for the study (define.xml, define.pdf, transport
files, annotated CRFs, and reviewers guide.)
· Review of SDTM domains and Specifications.
· Creation of TLF shells and approval of TLF metadata
· Produce TLFs for monthly Safety Review Committee
· A PhD in Statistics/Biostatistics and at least 5 years of
Pharmaceutical experience or a MS in Statistics/ Biostatistics and at least
7 years of Pharmaceutical experience are preferred.
· Knowledge of Statistics methodology in design and analysis, and
regulatory requirements relating to clinical development of drugs and
· Working Knowledge of major statistical software program
· Knowledge of CDISC requirements for SDTM and ADaM electronics
· Excellent verbal and written communication skills, and excellent
*408-709-1760 EXT 9859*
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