Sr Biostatistician (R1108140) in Bangalore, India at IQVIA™

Date Posted: 1/3/2020

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Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

The Sr Biostatistician will be responsible for delivering statistical analytic solu-tions for Medical Affairs studies (MA), Non-Interventional studies (NIS), Scientific Ana-lytics studies and  multiple Phase I-IV clinical trials at a trial level by executing statis-tical analyses plans, ensuring high quality and timely production of statistical report-ing deliverables (analysis datasets, tables, listings and graphs). Leads implementation of modern and innovative clinical trial/experimental designs, statistical models, anal-yses and data exploration at the study level. Is also responsible for the training and mentoring of other statisticians, and supporting project operational excellence. 
• Responsible and accountable for the statistical activities and support on sta-tistical solutions for studies/publications and conferences and support the tasks independently seeking peer inputs/ reviews as required. Activities in-clude protocol development in alignment with the development plan, providing inputs on statistical scientific and operational aspects of the planning, design and reporting of trials/experiments, and production and delivery of statistical deliverables and exploratory analyses. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician.
• Lead statistical/numerical/analytic research by providing advice and solutions on computational aspects of the problem.
• Guides the trial statistician to ensure that documents, specifications, pro-grams/macros are consistent and comply with company standards by provid-ing input into CRF and data structures tables, listings and figures for MA stud-ies, NIS and Scientific Analytic studies.
• Assume responsibility for reporting and analysis execution for multiple studies. Responsibilities include, leading statistical deliverable meetings with neces-sary clinical trial team members and third parties, and exploratory analyses for ad-hoc analyses. Expected to provide support for publications for individual clinical trials, and scientific analytical solutions.
• Oversee Biostatistics resources and deliverables for assigned trials and thera-peutic area level. Lead study teams to ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical relat-ed activities.
• Explain statistical methodology and interpret analysis results. Provide statisti-cal expertise to support all activities and documents, meetings with and re-sponses to customers and JOC meeting activities, as required.
• Maintain efficient interfaces with Lead Statistician, internal and external cus-tomers with support of CTS management, CROs and CPOs as needed.
• Take lead role to collaborate with other line functions including the clinical trial team. Explain statistical concepts in a manner easily understood by non-statisticians, and provide adequate statistical justifications for ac-tions/decisions/statements, when required.
• Develop and comply with project / study standards and specifications follow-ing internal guidelines.
• Support quality control and quality audit of deliverables.
• Provide input on process improvement initiatives and participate in non-clinical project activities with support from group head.
• Participate in non-clinical project activities as needed. Promote the use and the acceptance of innovative methods within the organization, through scien-tific collaborations, publications in scientific peer re-viewed journals and presentations at professional meetings.
• Provide support, coaching and mentoring to new hires, senior and junior stat-isticians.
• Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, confer-ences, scientific meetings.
• Manage the outsourcing of statistical activities from Data Science to an ap-proved vendor in accordance with Scientific Services vendor management pro-cedures.
• Assist the Biostatistics Group Lead in the assessment of applicants for statis-tician roles within Data Science.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Job ID: R1108140


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