Hiring for Global Pharma Company is Looking for Lead Biostatistics at Hyderabad in Hyderabad / Secunderabad, for Exp. 4 - 9 yrs at BVR People Consulting.

  • MedWiz
  • Hyderabad, Telangana, India
  • Dec 07, 2017
Full time General Admin, Others

Job Description

Job Description:Qualification - MSc Or M. Pharm (Statistics) Experience - 5 Years To 9 Years. Position - Biostatistics. Sample size and power estimation. Providing statistical inputs to protocol. Randomization schedule generation. Review CRF/eCRF Design, Metadata &amp amp amp Annotation. Write/Review Statistical analysis plan (SAP). SAS Programming &amp amp amp TLF generation. Perform a complete Statistical analysis (Efficacy and safety) and write interpretation to the clinical trial studies, PKPD &amp amp amp Post Market studies (Phase I-IV). Review Clinical Study Report (CSR). Collaborate with cross functional teams for all trial related activities. CRO/ in-house Project management &amp amp amp updates. Develop and implement functional SOPs. Generate Master Randomization schedule using SAS and in charge of controlled access/distribution. Provide statistical inputs for generation for protocols and review of protocols. Provide statistical support to the Data and Safety Monitory Board for clinical trails Write Statistical sections of integrated reports Develop analysis plans, table shells, and programming and table specifications. Perform data review and Statistical analysis for Phase III studies. Replying to sponsor/regulatory related queries. Understanding of Clinical trials and Clinical data. Creation of Summary Table, Listings and Datasets Using SAS. Create SAS programs to analyze data and produce tables and listings specified formats as per SAP. Validate and review the Statistical outputs, also develop statistical programs if required If you are looking for world class company kindly revert with your updated CV along with CTC,ECTC and Notice period to saritha@bvrpc.com