Lead Statistical Programmer

4 weeks ago

Bengaluru, India IN19 Alcon Laboratories (India) Pvt Ltd Company Full time
Summary Of Position:Key contributor responsible for quality, timely and cost efficient execution of all statistical programming aspects of assigned studies or project-level activitiesCustomary point of contact for Trial Statisticians and other members of the Clinical Trial TeamKey Responsibilities:Lead statistical programming activities as Trial Programmer for assigned studies or project-level activities including requirements analysis, resource estimation, planning and tracking, development of programs and validation of deliverablesDevelop and review programming dataset specificationsCoordinate activities of all programmers assigned to the same study or project. Conduct kickoff meeting to provide an overview of the study or project, discuss deliverables, roles and responsibilities, timelines, and conventionsRemove barriers to facilitate quality, timely and efficient completion of deliverables. Ensure that programmers have all required inputs for their tasksProvide solutions to programming issues and/or ensure efficient implementation.Build and maintain effective working relationships with relevant team functional representation. Effectively communicate the status of deliverables, changes to plan, risks and proposed mitigation strategy to relevant team, Project Programmer and supervisorContribute to development of SP standards and processes, knowledge sharing and other tasks as assignedResponsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis resultsKey Requirements/Minimum Qualifications:Quality and timeliness of all deliverables for assigned studies or project-level activitiesAbility and effectiveness in leading activities and coordinating programmers assigned to the same study or projectAdequate representation as Trial Programmer in the Clinical Trial Team.Effectiveness of communication and participation as assessed by the team membersCompliance with internal and external standards as measured by audit findingsWorks effectively under minimal supervision of supervisor or Project Programmer who is responsible for the overall statistical programming strategy for the projectTimely and high quality SP deliverables. Delays and errors in deliverables may impede submissions or other product developments and subsequent revenue loss to the companyEfficient programming leading to quality submissions, and reduced time and costs for development and registrationEnsuring external quality reputation of Alcon with Health AuthoritiesStrong SAS programming skills including development and use of macrosExtensive experience in requirements analysis, resource estimation, planning and tracking deliverables and coordinating activitiesExtensive experience in developing programming dataset specificationsGood working knowledge of statistical conceptsGood understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, ICH) and industry standards such as CDISCExcellent written and oral communicationAbility to work well with others globallyMinimum Requirements7 years of relevant experience in clinical Statistical programming & SDTM, ADAM, Analysis dataset and specification creation, (TLF)Table and Listing creation.

2 years of proven ability to lead statistical programming activities as Trial Programmer

BA/BS/MS degree or equivalent experience in mathematics, statistics, computer science, health sciences or related field

Preferred RequirementsRelevant programming experience is in the pharmaceutical or medical device industryWork hours:

1PM to 10PM ISTRelocation assistance:

YesEmployment scams:

Alcon is aware of employment scams which make false use of our company name or leader’s names to defraud job seekers. Alcon does not offer any positions without interview and never asks candidates for money. All our current job openings are displayed here on the Careers section of our website, where you can search for open positions and apply directly.If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information, and check our website for current job openings.

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