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Statistical Programmer

6.00 to 11.00 Years   Hyderabad   30 May, 2020
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaApplication Programming / Maintenance
EmploymentTypeFull-time

Job Description

ResponsibilitiesThe 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 (e.g. CDISC, 21 CFR Part 11, and electronic submissions).QualificationsSound Lead Statistical programming experience within related industry is essential (min 6 years)Proficiency in SASKnowledge of the programming and reporting processKnowledge 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 applicationDemonstrated application of CRS concepts to achieve best practice and promote continuous improvementDemonstrate ability to learn new systems and function in an evolving technical environmentStrong leadership ability.Ability to successfully work together with a ( virtual ) team (including international teams as required) as well as independentlyDemonstrate strong organizational skills, ability to manage competing priorities, and be flexible to changeAttention 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.EducationEducated to degree level in a relevant discipline and/or equivalent work experience,

Keyskills :
sassas programming sdtmdata management reportingclinical trial management system clinical data managementelectronic data capture

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