*Hi, **Hope you are doing great. Please go through the below mentioned requirement and share the profiles at **[email protected] <[email protected]>** 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* *[email protected] <[email protected]>* *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 [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/sap-abap. For more options, visit https://groups.google.com/d/optout.
