Senior Biostatistical Programming Specialist

7 days ago

lucknow, India beBeeProgramming Full time

Biostatistical Programming Lead RoleIn this esteemed position, you will spearhead the development of statistical programming procedures and processes for clinical trials. As a Biostatistical Programming Lead, your primary objective is to design, implement, and manage statistical programming projects from start to finish.You will be responsible for generating datasets, creating complex listings, tables, and graphs using SAS programming. Additionally, you will develop reviewer's guides, define.xml files, and ensure that data summaries are delivered in a consistent, high-quality manner.Your expertise in CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation will be invaluable assets to our team. You will work closely with internal and external functions to ensure project timelines and goals are met.ResponsibilitiesDesign and implement statistical programming procedures and processes for clinical trialsGenerate datasets, create complex listings, tables, and graphs using SAS programmingDevelop reviewer's guides, define.xml files, and ensure data qualityCollaborate with internal and external functions to meet project timelines and goalsMaintain and validate SAS and/or R programs tailored to clinical development programs' needsContribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macrosParticipate in the development of CRFs, edit check specifications, and data validation plansQualificationsTo be successful in this role, you must have:A minimum of 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or with a similar teamExceptional SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environmentExtensive applied experience of CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulationExcellent communication and leadership skills

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