Statistical Programmer II
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Job Title Statistical Programmer II
Department Global Data Operations
SBU CRS
Location All
Essential Function
The Statistical Programmer II provides technical expertise for the conduct of clinical trials, and works with
minimal supervision to support various programming activities related to the analysis and reporting of
clinical study data.
Relationships
Reports To Associate Manager, Manager or Senior Manager
Directly Supervises N/A
Provides Work Direction to Statistical Programmer I, Statistical Programmer II, as appropriate
Works Closely with Biostatisticians, Database Programmers, Data Operations Lead,
QMG, Clinical Data Analysts, RRC, Medical Writing,
External Relationships Sponsors, Third Party Vendors, Auditors
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
PAREXEL International
Job Description Template
(TP-HR-WW-001-03)
TP-HR-WW-001-03 JD Version Date: 24 Feb 2011
Template Effective Date: 24 Feb 2011 Page 2 of 2
Related to: SOP-HR-WW-001
• 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.
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
Language Skills
• Competent in written English.
• Good communication skills.
Minimum Work Experience
• Relevant Clinical Trial industry experience

Qualifications:
Relevant Clinical Trial industry experience
 
Additional Information
Location | | | Hyderabad Start Date 2013-07-18
Job Type Full Time
Salary Not Provided
Career Level Not Provided Relevant Work Experience Not Provided
Education Level Not Provided Job posted on 18-Jul-2013


Contact Information
Company Name PAREXEL Telephone No Not Provided
Contact Name Site Link Not Provided
 

       

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