Senior Lead Biostatistician

1 week ago

ghaziabad, India beBeeStatistical Full time

Lead Statistician in Oncology Clinical TrialsAs a statistician with experience in oncology clinical trials, you will be responsible for developing, validating, and maintaining datasets, tables, listings, and figures. You will also perform end-to-end statistical programming activities across all phases of the trial.Develop edit checks, data review listings, and derive specifications aligned with study requirementsPrepare programming specifications, data mapping documents, and validation checksCollaborate with biostatisticians, data managers, medical writers, and regulatory teams to ensure timely and quality deliverablesEnsure compliance with CDISC standards, regulatory guidelines, and company SOPsSupport automation, process optimization, and QC initiatives for continuous improvementKey Responsibilities:Detailed below are the responsibilities of this role:Conduct safety and efficacy analyses including AE summaries, lab evaluations, exposure-response analysis, and time-to-event outputsSchedule meetings with stakeholders to discuss progress and address concernsWrite technical reports detailing results and methodology usedRequired Skills & QualificationsBachelor's/Master's degree in Statistics, Computer Science, Life Sciences, Mathematics, or a related discipline7 years of hands-on Statistical Programming experience in clinical trials (Oncology domain preferred)Strong working knowledge of ISS or ISE programming submissionsExpertise in creating safety and efficacy analysis outputs and submission packagesExperience in edit checks development, dataset specifications and derivation logic writingStrong problem-solving, analytical, and documentation skillsAbility to work independently along with effective stakeholder communicationWhy Choose This Role?This is an excellent opportunity to advance your career in a dynamic and fast-paced industry. As a statistician in this role, you will have the chance to work on challenging projects, collaborate with a talented team, and develop your skills in a supportive environment.You will also have access to training and development opportunities to help you grow professionally and personally.Contact Us: For more information about this role, please get in touch with us using the contact details provided.

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