Description
New Contract Opportunity!!Biostatistician
6 month contract
Central New Jersey
Contract Research Organization
My Direct Client is URGENTLY seeking a talented and motivated Biostatistics Consultant to join their Biostats & Data Mgmt department .This position is responsible for implementing and executing methodological and statistical aspects of clinical studies with direction from lead biostatistician or project lead statistician. Provide leadership and guidance on statistical matters to interdepartmental clinical / regulatory teams. In some cases principal function could be to develop / employ technical expertise in a particular statistical area or application.
-Support/participate in the development of clinical program
-Review protocols and CRFs for soundness of trial design
-Write statistical methodology section of the protocol
-Develop statistical analysis plan (SAP), programming specifications, and SAS programing for derived dataset and validate TFLs
-Perform inferential analyses; inputs to the statistical section of the clinical study report and review clinical study report
-Support/participate in project related activities including preparation of BLA submissions and oversee CR0 deliverables for studies contracted out
-With periodic supervision and guidance from senior departmental staff, provide support and leadership to a clinical study team on all relevant statistical matters
-Act as liaison to study team, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis.
-Work with programming team to provide definitions, documentation, and review of derived variables needed to produce planned TFL
-Perform statistical analysis defined in SAP, prepare statistical methods and results sections for the clinical study report (CSR), and work with the study team to move the CSR through review and approval process
-Produce / coordinate production of statistical summaries, analyses, annual reports, and related materials for submission to regulatory authorities
-Provide assistance to project biostatistician or Therapeutic Area lead biostatistician
MUST HAVE:
PhD with Industry experience OR Masters Degree with 5 years experience in Pharmaceutical/CRO Environment.
Please send me an update resume ASAP. REFERRALS WELCOME! All my contact details are on Linkedin, Search for Paul Dai.
Call or email me if you have any questions.
Thanks
Paul Dai
To find out more about Real please visit www.realstaffing.com