Title: BiostatisticianLocation: Hyderabad The incumbent will provide statistical expertise and contribution in the conduct of human subjects research during clinical development and life cycle management
As a study biostatistician for statistically standard clinical studies and under supervision:Act as Statistical subject matter expert at study team levelprovide statistical input for concept sheet/protocol/CRF development (eg
, study design; sample size estimation for the most efficient and practical design; patient randomization; accurate, logical, clear, concise and thorough statistics section; effective CRF specifications to collect data specified in the protocol, ensure blinding/unblinding measure are taken to ensure data integrity) with supervision
author medical and statistical supervision plans, write statistical analysis plans including the most appropriate statistical methodology and data presentations and provide specifications for analysis datasets
perform statistical analyses or validate statistical output as required or able to conduct oversight of vendor for these studies
write comprehensive statistical methods sections for the clinical study report; critically review and coauthor these reports ensuring the accuracy of the statistical interpretation
With surpervision, able to effectively perform ad hoc analysis or project related standard reporting (eg, DSUR)
understand and follow all Global Biostatistics WIs/SOP and relevant Standards as well as any other relevant WIs/SOPs
May act as an interface between programming and statistic
The responsibilities include but are not limited to performing complex statistical analyses
Who You Are:Qualification:MS in Statistics, Biostatistics or related disciplineRequired Experience:2-3 years of relevant experienceKey Skills:SAS and R practical and effective knowledgeAbility to develop an understanding of relevant clinical therapeutic areasResults driven CollaborativeAct purposefullyFluent in English (written and spoken)