Company Description
MakroCare | A MakroGroup Company | www.MakroCare.com
MakroCare is an Expert Strategic Development and Commercialization Global Partner for the
Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes
bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical
Research, Medical/Scientific Support and Emerging Region Expansion.
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical
Device Clinical Investigations)
Eligibility Criteria:
Education: Masters's degree in Statistics / Biostatistics.
Experience and Skills: 3+ years of experience within Clinical Trials/BA BE Industry, CDISC & SAS
Job Description:
Preparation and Review of Statistical Analysis Plan (SAP)
Preparation and Review of Mock Tables, Listings and Figures (TLFs)
Preparation and Review of Statistical Analysis Report (SAR)
Involve in a statistical review of final deliverables to the client
Involve in the planning and design of the study
Preparation and Review of inputs for the protocol development including sample size calculation and randomization
Preparation and Review of Biostat quote preparation for proposed studies
Review of Case Report Form (CRF)
Preparation of critical data points for CDM team
Preparation and Review of programming specifications for Analysis datasets creation
Review of Clinical Study Report (CSR)
Any other responsibilities assigned by the Director - Biostatistics as and when the need arises
Maintain 100% Quality and on-time delivery of the above activities