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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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Group Leader

Build and operationally manage a local team of statistical programmers and Data managers who provide support for a portfolio of drug projects in US Medical. Participate in development of Statistical Analyses Plan (SAP), develop and QC original SAS programs for data mining, efficacy and safety analyses for publications, and take responsibility for DB Locks and trial level programming activities (analysis datasets, pooled datasets, tables, listings and figures). Deliverables must satisfy regulatory requirements and of high quality. Contribute to the development of Statistical Sciences group and its long-term goals and operating policies through his/her leadership role on the management team. 2. Recruit talent, coach and develop reports on site. 3. Manage a group of statistical programmers and data managers assigned to multiple project portfolios. 4. Manage timelines, quality and preparation of statistical sciences deliverables and ensure that they comply with Novartis project and regulatory guidelines. 5. Develop and implement relevant SOPs and Working practices. 6. Make certain that documents and specifications provided by CROs are consistent and comply with Novartis standards by providing early input into data management deliverables and templates for TLFs for outsourced phase I-IV clinical trials and submission activities. 7. 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. 8. In consultation with the trial statistician, develop specifications for analysis datasets, pooled datasets, and Tables, Listings and Figures (TLFs); develop original SAS programs and deliver quality output: analysis datasets, pooled datasets, and TLFs for US phase I-IV clinical trials and publications; develop SAS programs to help data managers for checking data quality. 9. QC Clinical Research Organization (CRO) delivered programs and TLFs for outsourced clinical trials. 10. Maintain records for all assigned projects and archive trial/project programs, analyses and associated documents. 11. Provide input on process improvement initiatives and participate in non-clinical project activities with support from the Group Head. 12. Respond to Health Authority / FDA / audit requests pertaining to project-specific programming issues. 13. Lead and support clinical and non-clinical special projects Desired Profile Master degree in statistics, mathematics, computer science or equivalent. Fluent in English (oral and written). . . At least 8 years of experience in clinical trials, including 6 years of experience as a statistical programming role within the pharmaceutical industry. 2. Excellent knowledge and skills of statistical programming language, SAS. 3. Good knowledge of drug development process, statistics and data management. 4. Experience with matrix management and global environment. 5. Track record in successful project management and people management. 6. Knowledge of Health Authority guidelines. 7. Proven ability to proactively identify issues, communicate awareness and recommend/implement solutions Experience 8 - 10 Years Industry Type Pharma / Biotech / Clinical Research Role Technical Lead/Project Lead

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