Senior Statistical Programmer I
South Africa
ICON plc
ICON is the world's leading clinical research organisation, providing outsourced clincal development and commercialisation services to the pharmaceutical, biotechnology and medical device industries.Overview
As a Senior Statistical Programmer I you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What you will be doing:
- Services rendered will adhere to the client's SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
- Clear communication with partnering departments: Data Management, Statistics, Statistical Programming and Bio-analytical providers.
- Ensures quality NONMEM input data (accurate, valid and complete) is provided to the Pharmacometrics Leaders within projected timelines for low to medium complexity projects.
- Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements.
- Programming and QC of NONMEM PK/PD datasets based on SDTM/ADAM datasets.
- Follow up and QC of outsourced NONMEM datasets.
- Prepare submission projects per internal PM guideline.
- QC of existing, customized R packages used for standardization of Pharmacometric works (build testing suite of customized packages).
- Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables.
- Critically reviews requirements and data, identifies gaps, suggests solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Involved as active driver in development of new PM standardization efforts.
Qualifications
You are:
- BA/BSc degree in a health or science related field. IT degree can also be considered if working knowledge with R software.
- Strong working knowledge of R software (important)
- Interest in PK/PD and clinical trial concepts.
- Studious and data driven person. Eye for detail is very important.
- Proficient in speaking and writing in English. Effective communication skills, oral and written.
- Knowledge of SDTM, ADAM and controlled terminology concepts.
- Knowledge of PK/PD principles
- Previous experience in applying standardization efforts for NONMEM file creation submission, and QC.
What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
* Salary range is an estimate based on our AI, ML, Data Science Salary Index 💰
Tags: Data management GCP R Research Statistics Testing
Perks/benefits: Competitive pay Flex hours Health care Insurance Medical leave
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