*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* -- You received this message because you are subscribed to the Google Groups "SAP ABAP" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-abap+unsubscr...@googlegroups.com. To post to this group, send email to sap-abap@googlegroups.com. Visit this group at https://groups.google.com/group/sap-abap. For more options, visit https://groups.google.com/d/optout.
