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Senior Statistical Programmer

Bengaluru, KA
Job Code:
  • Biotechnology & Science
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Job Details

Deliver best value and high quality service Ability to fill Statistical Programming Coordinator role on projects. The Statistical ProgrammingCoordinator willo Input into and negotiate statistical programming timelines. Ensure that timelines areadhered to.o Coordinate and lead a statistical programming team to successful completion of a studywithin given timelines and budgeto 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 globalprograms (e.g.,,, etc.), tracking spreadsheets, and required documentation. Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, deriveddataset specifications, programming specifications, and other process supporting documents. Use efficient programming techniques to produce and/or QC derived datasets tables, figures anddata listings. Understand regulatory requirements concerning industry technical standards (e.g., CDISC, 21 CFRPart 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 toensure traceability and regulatory compliance Be trained in sponsor WSOPs and disseminate knowledge to project team members asappropriate. Proactively participate in and/or lead process/quality improvement initiatives Work closely with the Quality Management Groups (QMG) to ensure compliance withWSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations andparticipate in internal/external audits and regulatory inspections as required Develop wider knowledge of SAS and other relevant programming languages and processeswithin 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 teamsQualifications Proficiency in SAS Knowledge of the programming and reporting process Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any otherapplicable local and international regulations such as 21 CFR Part 11 and proven practicalapplication Demonstrate ability to learn new systems and function in an evolving technical environment. Strong leadership abilityAbility to successfully work together with a (virtual ) team (including international teams asrequired) as well as independently Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible tochange Good business awareness/business development skills (including financial awareness)Work effectively in a quality-focused environment Demonstrate commitment to refine quality processes Effective time management in order to meet daily metrics or team objectives Show commitment to and perform consistently high quality work Educated to degree level in a relevant discipline and/or equivalent work experience Competent in written and oral English. Excellent communication skills. Relevant Clinical Trial industry experience
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 2-6


Data Management/ Statistics | Quality Assurance/ Control | Technology Transfer Engineer
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