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Saturday, September 12, 2015

Senior Statistical Programmer PAREXEL International Corporation by pharmanaukri.in

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 programming activities related to the analysis and reporting of clinical study data. In addition, the Senior Statistical Programmer can fill the Statistical Programming Coordinator role on projects, and liaise with sponsors, Data Operations Leads, and other functional areas as required.
Qualifications
Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming Coordinator will:

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
Interact with Sponsors as the key contact with regard to statistical programming issues
Provide technical support and advice to the internal team
Check own work in an ongoing way to ensure first-time quality
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
Coordinate 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 analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents
Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.
Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFR Part 11, electronic submissions, etc.) and implications for the department
Provide input into monthly PERFORM forecasts and monitor the completion of forecasted units
Create standard macros and applications to improve the efficiency of the department
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 SAS and other relevant programming languages 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 relevant training and mentorship to staff and project teams

Salary: Not Disclosed by Recruiter
Industry: IT-Software / Software Services
Functional Area: Analytics & Business Intelligence
Role Category: Data Analyst
Role: Data Analyst
Keyskills: SAS, Statistical Programming, Macros, Clinical Trials, Biostatistics, QC, Quality Management, Process Quality, Quality Improvement, Quality Standards, Data Analyst
Desired Profile
 
Education:UG -Any Graduate - Any Specialization 
PG - Any Postgraduate - Any Specialization, Post Graduation Not Required 
Doctorate - Doctorate Not Required
Company Profile
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in approximately 70 locations throughout over 50 countries around the world, and has more than 13,000 employees. At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You'll be surrounded by supportive leadership and a brilliant team who share a common goal - to improve the lives of millions of patients.

Contact Details
Recruiter Name:Not Mentioned
Contact Company:PAREXEL International (India) Pvt Ltd
Telephone:Not Mentioned
Reference Id:post-00022834

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