Clinical Trials Specialist

1 week ago


Koṭa, India beBeeBiostatistician Full time

Senior Biostatistician and Programmer RoleThe successful candidate will have the opportunity to work on a variety of clinical development programs across different therapeutic areas, collaborating with internal and external teams to ensure timely delivery of high-quality statistical programming results. The role involves implementing reporting and analysis activities for clinical trials, generating datasets, complex listings, tables, and graphs using SAS and R programming languages.Key Responsibilities:Develop and maintain SAS and/or R programs tailored to clinical development programs' needsGenerate SDTM, ADaM specifications, datasets, reviewer's guide, and define.xml files for multiple studiesDeliver high-quality statistical programming results, including developing, validating, and maintaining SAS and/or R programsSupport preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analysesRequirements:Bachelor's degree in computer science, data science, mathematics, or statistics major preferredAt least 7 years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar teamExceptional SAS programming skills and expertise in implementing statistical programming procedures and processesExtensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml)Strong communication and leadership skillsPreferred Qualifications:Prior work experience with pharmacokinetic data and neuroscience fieldProficiency in languages or tools other than SAS (e.g., R, Python, Java, Shiny, Markdown, Unix/Linux, and git)



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