Job Description

Summary Of Position:Alcon is looking to hire Lead Statistical Programmer who is responsible for driving productivity and accuracy relative to set strategies and objectives across the AGS regulatory operations team.

• Key contributor responsible for quality, timely and cost efficient execution of all statistical programming aspects of assigned studies or project-level activities
• Customary point of contact for Trial Statisticians and other members of the Clinical Trial Team

Key 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 deliverables
• Develop and review programming dataset specifications
• Coordinate 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 conventions
• Remove barriers to facilitate quality, timely and efficient completion of deliverables. Ensure that programmers have all required inputs for their tasks
• Provide 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 supervisor
• Contribute to development of SP standards and processes, knowledge sharing and other tasks as assigned
• Responsible for quality control and audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results

Key Requirements/Minimum Qualifications:

• Quality and timeliness of all deliverables for assigned studies or project-level activities
• Ability and effectiveness in leading activities and coordinating programmers assigned to the same study or project
• Adequate representation as Trial Programmer in the Clinical Trial Team.
• Effectiveness of communication and participation as assessed by the team members
• Compliance with internal and external standards as measured by audit findings
• Works effectively under minimal supervision of supervisor or Project Programmer who is responsible for the overall statistical programming strategy for the project
• Timely and high quality SP deliverables. Delays and errors in deliverables may impede submissions or other product developments and subsequent revenue loss to the company
• Efficient programming leading to quality submissions, and reduced time and costs for development and registration
• Ensuring external quality reputation of Alcon with Health Authorities
• Strong SAS programming skills including development and use of macros
• Extensive experience in requirements analysis, resource estimation, planning and tracking deliverables and coordinating activities
• Extensive experience in developing programming dataset specifications
• Good working knowledge of statistical concepts
• Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, ICH) and industry standards such as CDISC
• Excellent written and oral communication
• Ability to work well with others globally

Minimum 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 ProgrammerBA/BS/MS degree or equivalent experience in mathematics, statistics, computer science, health sciences or related fieldPreferred 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\xe2\x80\x99s 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.ATTENTION: Current Alcon Employee/Contingent WorkerIf you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.

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