Deliver best value and high quality service
Ability to fill Statistical Programming Coordinator role on projects. The Statistical Programming
o Input into and negotiate statistical programming timelines. Ensure that timelines are
o Coordinate and lead a statistical programming team to successful completion of a study
within given timelines and budget
o 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
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: INR 50,000 P.A.
Industry: Pharma / Biotech / Clinical Research
Functional Area: Other
Employment Type: Permanent Job, Full Time
Quality Control Production SAS Quality Management Process Quality Quality Improvement Quality Standards Regulatory Compliance Statistical Programming Service Quality
Desired Candidate Profile
Please refer to the Job description above
PAREXEL International (India) Pvt. Ltd.
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of expertise-based contract research, consulting, medical communications, and technology solutions and 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. PAREXEL Informatics provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL has offices nearly 80 locations in over 50 countries around the world, and has approximately 18,000 employees.
In India, PAREXEL has seven offices spread across five cities: Bengaluru, Hyderabad, Chandigarh, New Delhi and Mumbai. These offices are home to more than 3,000 employees.
Our two new offices in Bengaluru, called IndiQube and EcoWorld, were strategically designed to support a variety of work styles. There are collaboration zones in bright colors, freestanding high tables with stools to serve as informal meeting spaces, quiet rooms for group meetings, and private booths for phone calls. This innovative workspace encourages teamwork, and allows for sufficient flexibility to utilize the office beyond workstations.