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Merck KGaA
Title: Senior BiostatisticianLocation: Hyderabad Job Description: 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 (e.g., 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 (e.g., 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:3-4 years of relevant experience / PhD with no 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) We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, colour, religion, sex, age, disability, marital status, sexual orientation, and gender identity.
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