Job description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
ICON Government and Public Health Solutions (IGP) is a full-service CRO specializing in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ICON Government and Public Health Solutions has a distinct ability to provide rapid response efforts to global health crises.
The Sr. Statistical Programmer is responsible for completion of the following: Create, validate, execute and generate statistical programs consisting of listings, safety and efficacy outputs (analysis datasets, tables, figures) in accordance with documented procedures and project specific timelines, to generate accurate, complete and consistent outputs. In addition, the Statistical Programmer may create project or departmental level macros, programming specifications/mockups and support other project activities, as required.
Read, ensure understanding and adhere to all assigned ICON GPHS SOPs and working procedures.- Record all billable and non-billable time accurately into the appropriate time management system.
- Complete all assigned training, including any mandatory training courses in ICON GPHS's Training Management System in compliance with ICON and departmental policies. Perform the following tasks per project specific timelines as deemed appropriate to level.
- Adhere to programming specifications and study specific requirements, including completion and filing of required documentation.
- Plan, organize and prioritize workload to ensure effective time management and adherence to project specific timelines.
- Efficient use of SAS, and adherence to SAS programming guidelines.
- Create listing and safety outputs (analysis datasets, tables, figures) to a high standard of quality and accuracy.
- Validate listing and safety outputs (analysis datasets, tables, figures) per departmental procedures.
- Create efficacy outputs (analysis datasets, tables, figures) to a high standard of quality and accuracy.
- Create, document and validate macros at the table, listing and figure level.
- Maintain PDVD according to the procedures for Planning, Executing, Tracking and Documentation of Programming and Validation activities.
- Trouble-shoot and resolve programming issues in a timely and efficient manner.
- Perform the following tasks per project specific timelines under supervision, as deemed appropriate to level:
- Validate efficacy outputs (analysis datasets, tables, figures) per departmental procedures.
- Create complex programs (such as project or departmental macros) to a high standard of quality and accuracy
- Create analysis dataset specifications and tables, figures and listing mockups.
- Set- up standard programming directories and start-up utilities.
- Liaise effectively with other ICON functions (e.g., DM, MW), as required during the life of the project.
- Participate in the review of in- progress audit findings and implement corrective actions, as required.
- Facilitate flow of information on study budgets and change order management in a timely and efficient manner.
- Proactively communicate and work effectively with biostatisticians and data management teams.
Master’s Degree or Bachelor’s Degree with experience. Preferred degrees in epidemiology, statistics, computer science, mathematics, or other related degrees.- Proficiency in SAS programming and using SAS macros for data set generation and statistical procedures to support clinical trials.
- CDISC SDTM and ADaM dataset development and validation is required.
- Experience in supporting clinical research and trial for a CRO/Pharmaceutical/Biotech company.
- Proficient in Microsoft Office Suite.
- Ability to work well in a team environment as well as independently as needed.
- Ability to problem-solve
- Exceptional written and oral communication skills.
- An understanding of quality control as it relates to regulatory documentation requirements is preferred.
- Experience in R programming is not required but is a plus.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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