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Senior Statistical Programmer

5.00 to 7.00 Years   Hyderabad   25 Oct, 2019
Novartis Healthcare Pvt Ltd
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Your responsibilities: Your responsibilities include, but are not limited to:

  • Lead the programming activities for a trial or publication activities.
  • Maintain efficient interfaces with internal and external customers with support of CDS management, Program Programmer/Statistician and CPOs as needed.
  • Develop resource plans as required with support of the Program Programmer.
  • Develop and comply with project / study standards and specifications following internal guidelines.
  • Make certain that documents and specifications are consistent and comply with company standards by providing input into CRF and data structures tables, listings and figures for phase I-IV clinical trials and submission activities.
  • Program and deliver, according to specifications, analysis datasets, pooled datasets, listings, tables, and figures for clinical trials with high quality and within milestones.
  • In consultation with the statistician, develop specifications for analysis datasets, pooled datasets, and listings
  • As required, make certain that documents and specifications are consistent and comply with company standards for specifications of analysis datasets, pooled datasets, listings, summaries, figures and tables for clinical trials.
  • Support quality control and quality audit of deliverables.
  • Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation
  • Participate in the selection of CROs and supervise the trial activities of the CROs as needed.
  • Provide input on process improvement initiatives and participate in non-clinical project activities with support from GH

Minimum requirements

University or college degree in life science, computer science, statistics or equivalent relevant degree. Fluent English (oral and written).

  • Intermediate knowledge of / experience with SAS software.
  • Working knowledge of database design/structures.
  • Good understanding of global clinical trial practices, procedures, methodologies.
  • Good understanding of regulatory requirements relevant to SR (e.g. GCP, ICH).
  • Intermediate knowledge of office tools.
  • 5 - 7 years experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry.
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Keyskills :
gcp programming qc adam compliance processimprovementinitiatives qualityaudit qualitycontrol datastructures clinicaltrials computerscience projectanalysis processimprovement regulatoryrequirements ummarizin

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