Dedicated Clinical Data Specialist

5 days ago

kakinada, India beBeeStatistical Full time

Senior Statistical Programmer RoleSponsor-dedicated, you'll be working fully embedded within one of our pharmaceutical clients, with the support of Cytel behind you.About the Position:This position reports to the Director, Biostatistics and Programming in our FSP Services business unit. The Senior Statistical Programmer works independently with concept-level instruction and minimal supervision; tracks progress and provides expert technical support to team members. We're seeking a highly experienced senior statistical programmer who will work on clinical development programs across various therapeutic areas and oversee CRO programmers to ensure high-quality data summaries.Main Responsibilities:Data Preparation: Generate SDTM, ADaM specifications, datasets, reviewer's guide, and define.xml files for multiple studies.Programming and Analysis: Develop SAS programs that generate datasets, complex listings, tables (including descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs.Result Delivery: Deliver high-quality statistical programming results by developing, validating, and maintaining SAS and/or R programs tailored to clinical development program needs.CRO Oversight: Participate in overseeing CRO's statistical programming deliverables for multiple clinical studies to ensure high-quality and meet pre-specified timelines.Study Reports: Support preparation of clinical study reports, regulatory submissions, publications, annual DSUR, and exploratory analyses.Regulatory Compliance: Understand and follow FDA regulations affecting clinical trial data reporting, including good clinical practice and guidelines for electronic submissions.You'll collaborate with internal and external functions to ensure meeting project timelines and goals. This role involves contributing to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros. You'll also participate in the development of CRFs, edit check specifications, and data validation plans.About Us:We empower individuals to work with autonomy and ownership, driving innovation in patient treatment. This is an exciting time to join our global pharmaceutical client, where you'll be part of their next-generation program.Key Qualifications:Highly experienced senior statistical programmer with expertise in clinical development programs.Ability to work independently with minimal supervision and provide expert technical support to team members.Excellent communication and collaboration skills, with experience working with internal and external functions.Familiarity with FDA regulations and guidelines for clinical trial data reporting.This role offers opportunities for growth, professional development, and contributions to cutting-edge projects. If you're passionate about statistical programming, patient-focused innovation, and collaborative teamwork, we encourage you to apply for this challenging and rewarding opportunity.

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    kakinada, India beBeeMedicalWriter Full time

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    kakinada, India beBeeProgrammer Full time

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    kakinada, India beBeeWriter Full time

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    kakinada, India beBeeStatistical Full time

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    kakinada, India beBeeQuality Full time

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    kakinada, India beBeeStatistical Full time

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