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Novartis Healthcare Pvt Ltd

Novartis (NYSE: NVS) is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health. Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stoc... Read More

Address      Sandoz House Shivsagar Estate Dr Annie Besant Road Worli, Mumbai India
Website      www.novartis.in/
Holding      No Holding Details

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Senior Statistical Analyst

Participate in development of Validation and Analysis Plan (VAP), Statistical Analyses Plan (SAP), develop and QC original SAS programs for data mining, efficacy and safety analyses for publications, and take responsibility for trial level programming activities (analysis datasets, pooled datasets, tables, listings and figures) and/or statistical aspects of individual Phase I-IV clinical trials under the guidance of a senior statistician. Participate in the preparation of VAP, SAP, develop and QC original SAS programs for data mining and exploratory analyses of data for publications and new study design. 2. In consultation with the trial statistician, develop specifications for analysis datasets, pooled datasets, and Tables, Listings and Figures (TLFs). 3. Develop original SAS programs and deliver, according to specifications, analysis datasets, pooled datasets, TLFs for US phase I-IV clinical trials and for pooled analyses with high quality and within milestones. 4. QC Clinical Research Organization (CRO) delivered programs and TLFs for outsourced clinical trials. 5. Develop SAS programs to help data managers for checking data quality. 6. Make certain that documents and specifications are consistent and comply with company standards by providing input into CRFs, data structures, and templates for TLFs for outsourced phase I-IV clinical trials and submission activities. 7. Maintain records for all assigned projects and archive trial/project programs, analyses and associated documents. 8. Provide input on process improvement initiatives and participate in non-clinical project activities with support from the Group Head. 9. Respond to Health Authority / FDA / audit requests pertaining to project-specific programming issues. 10. Provide input, review, and maintenance of local working practices and standards. 11. Help the Group Head in hiring, mentoring, and training of other staff in the group. Desired Profile University or college degree in statistics, biostatistics, mathematics or computer science; master degree in statistics or biostatistics will be preferred. Fluent in English (oral and written). .1. Four (4) years of relevant experience with a bachelor degree or 2 years with a master degree in statistics or biostatistics. 2. Proven skills for efficacy analyses of clinical trial data using SAS. 3. Expert level SAS programming skills, including SAS Base, SAS Stat, SAS Macros, and SAS Graphs. 4. Experienced as a trial programmer for multiple clinical trials. 5. Experience in data pooling and data mining of clinical trial data and observational studies. 6. Good technical and problem solving skills. 7. Good understanding of drug development process, clinical trial methodology, GCP, medical terminology, and coding. 8. Ability to work with minimal supervision, under pressure, demonstrating initiative and flexibility. 9. Attention to details and quality focused. 10. Good interpersonal and communication skills and ability to operate effectively in an international environment. Experience 2 - 4 Years Industry Type Pharma / Biotech / Clinical Research Role Bio-Statistician

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