Statistical Programmer Ii Job in Parexel International Corporation
Statistical Programmer Ii
Parexel International Corporation
4+ weeks ago
- Hyderabad, Telangana
- Not Disclosed
- Full-time
Job Summary
Key Accountabilities
? Deliver best value and high quality service.
? 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.
? Assist in the coordination of project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g. setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
? Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents.
? Use efficient programming techniques to produce derived datasets, tables, figures and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures and data listings.
? Check own work in an ongoing way to ensure first-time quality.
? Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
? Proactively participate in quality improvement initiatives.
? 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 SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.
? Provide relevant training and mentorship to staff and project teams as appropriate.
? Assist project teams in the resolution of problems encountered in the conduct of their daily work.
? 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 specification for data exports in accordance with applicable standards.
? 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.
? Demonstrate ability to learn new systems and function in an evolving technical environment
? Attention to detail.
? 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.
? Business/Operational skills that include customer focus, commitment to quality management and problem solving.
? Work effectively in a quality-focused environment.
? Effective time management in order to meet daily metrics or team objectives.
? Show commitment to and perform consistently high quality work.
Education
? First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience.
? Deliver best value and high quality service.
? 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.
? Assist in the coordination of project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g. setup.sas, formats.sas, etc.), tracking spreadsheets, and required documentation.
? Assist in the production and QC of derived dataset specifications, programming specifications, and other process supporting documents.
? Use efficient programming techniques to produce derived datasets, tables, figures and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures and data listings.
? Check own work in an ongoing way to ensure first-time quality.
? Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
? Proactively participate in quality improvement initiatives.
? 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 SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.
? Provide relevant training and mentorship to staff and project teams as appropriate.
? Assist project teams in the resolution of problems encountered in the conduct of their daily work.
? 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 specification for data exports in accordance with applicable standards.
Qualifications
Skills:? 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.
? Demonstrate ability to learn new systems and function in an evolving technical environment
? Attention to detail.
? 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.
? Business/Operational skills that include customer focus, commitment to quality management and problem solving.
? Work effectively in a quality-focused environment.
? Effective time management in order to meet daily metrics or team objectives.
? Show commitment to and perform consistently high quality work.
Education
? First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience.
Experience Required :
Fresher
Vacancy :
2 - 4 Hires
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