*Hi, **Hope you are doing great. Please go through the below mentioned
requirement and share the profiles at **a...@tresourceinc.com
<a...@tresourceinc.com>** ASAP.*

*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
programming.

·          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



*Experience Required*

·          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
biologics.

·          Working Knowledge of major statistical software program
including SAS.

·          Knowledge of CDISC requirements for SDTM and ADaM electronics
submissions.

·          Excellent verbal and written communication skills, and excellent
interpersonal skills.



*Regards,*

*Ali*

*a...@tresourceinc.com <a...@tresourceinc.com>*

*408-709-1760 EXT 9859*

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