• Statistics Jobs in Mumbai,India - 25369370

  • PAREXEL International Ltd
  • Save Job
  • 6 - 9 Years
  • Posted : above 1 month

Job Description:

The Senior Statistical Programmer provides technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programing activities related to the analysis and reporting of clinical study data
In addition, the Senior Statistical Programmer can fill the Primary Statistical Programmer role on projects, and liaise with sponsors, Biostatistics Leads, and other functional areas as required
Further, the Senior Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets

Ability to fill Primary Statistical Programmer role on projects (Input into and negotiate statistical programming timelines, Ensure that timelines are adhered to, Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget, Monitor project resourcing, project budgets, and identify changes in scope)
Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation
Review statistical analysis plans and mock-shells
Review database set-up specifications and third-party vendor data transfer specifications
Interact with sponsors with regard to statistical programming issues
Deliver best value and high quality service
Check own work in an ongoing way to ensure first-time quality
Use efficient programming techniques to produce/QC SDTM datasets, ADaM datasets, tables, figures, and data listings
Develop knowledge of SAS and processes/procedures within other Parexel functional areas
Produce/QC SDTM dataset specifications, ADaM dataset specifications, and other process supporting documents including submission documentation
Interact with sponsors with regard to statistical programming issues
Maintain and expand local and international regulatory knowledge within the clinical industry
Develop knowledge of SAS and processes/procedures within other Parexel functional areas
Provide relevant training and mentorship to staff and project teams as appropriate
Develop knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, and processes/procedures within other Parexel functional areas
Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance
Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required
Proactively participate in process/quality improvement initiatives
Provide consultancy to internal and external sponsors with regard to statistical programming tasks
Represent Parexel at sponsor marketing and technical meetings
Understand regulatory requirements concerning industry technical standards (eg CDISC, 21 CFR Part 11, and electronic submissions) Qualifications Sound Lead Statistical programming experience within related industry is essential (min 6 years)
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

Education Educated to degree level in a relevant discipline and/or equivalent work experience

Language Skills Competent in written and oral English
Excellent communication skills

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Biotechnology/Pharmaceutical/Medicine
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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