• SAS Programmer Jobs in Mumbai,India - 24980484

  • PAREXEL International Ltd
  • Save Job
  • 0 - 3 Years
  • Posted : above 1 month

Job Description:

Key Accountabilities
Deliver best value and high quality service
Ability to fill Statistical Programming Coordinator role on projects The Statistical Programming Coordinator will
o Input into and negotiate statistical programming timelines Ensure that timelines are adhered to
o Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget
o Monitor project resourcing, project budgets, and identify changes in scope
Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed
Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance
Be trained in sponsor WSOPs and disseminate knowledge to project team members as appropriate
Proactively participate in and/or lead process/quality improvement initiatives
Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required
Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, SQL, and other programming language usage and processes within the GRO, biostatistics, and medical arenas
Maintain and expand local and international regulatory knowledge within the clinical industry
Assist project teams in the resolution of problems encountered in the conduct of their daily work
Provide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both PAREXEL and sponsors
Provide broad support, including advice on new technologies and industry technical standards (eg EDC, CDISC, Statistical principles, CFR Part 11, electronic submissions, applications and communications technologies, etc) and their integration into Programming processes
Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities
Provide consultancy to internal and external sponsors with regard to statistical programming tasks In addition, maintain visibility to these sponsors to ensure expectations are being met and that requirements are accurately distributed to the appropriate stakeholders
Provide oversight and guidance on multiple-trial programs, complex trials, and submission projects (including Integrated Summary of Safety or Efficacy)
Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (eg setupsas, formatssas, etc), tracking spreadsheets, and required documentation
Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents
Contribute to the development and delivery of internal and external technical training seminars and courses
Mentor and train other members of the department
Lead and supervise and/or create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request
Develop mapping specifications for data exports in accordance with applicable standards Qualifications Proficiency in SAS
Knowledge of the programming and reporting process
Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
Demonstrated application of CRS concepts to achieve best practice and promote continuous improvement
Demonstrate ability to learn new systems and function in an evolving technical environment
Strong leadership ability
Ability to successfully work together with a (virtual) team (including international teams as required) as well as independently
Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change
Attention to detail
Excellent analytical skills
Good presentation skills
Tenacity to work in an innovative environment
Ability to negotiate and influence in order to achieve results
Business/Operational skills that include customer focus, commitment to quality management and problem solving
Good business awareness/business development skills (including financial awareness)
Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial
Work effectively in a quality-focused environment
Demonstrate commitment to refine quality processes
Effective time management in order to meet daily metrics or team objectives
Show commitment to and perform consistently high quality work

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Biotechnology/Pharmaceutical/Medicine
Functional Area : IT Software : Software Products & Services
Role : Business/Systems Analysis
Salary : As per Industry Standards
Deadline : 06th May 2020

Key Skills:

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