As a Principal Statistical Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
- Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
- Creation of ADaM datasets based on current ADaM standards
- Creation of Tables, Listings and Figures following Janssen specifications
- Creation of Subject Narratives following Janssen templates too support Narrative development
- Creation of other ancillary data streams including (but not limited to) clinical registry reporting files (e.g. Clintrials.gov, EudraCT), Bioresearch monitoring reports (BIMO).
- QC of all programmed output
- Creation and/or maintenance of detailed specification documentation
- Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA and other regulatory agencies as needed.
- Includes support for standalone studies as well as integration of data across studies.
Interfaces – Primary/Other:
- Primary interfaces: Provider Functional Manager, Johnson & Johnson Point of Contact, Janssen project lead programmer
- Other Interfaces: Programming or biostatistics staff from partner contract research organizations (CRO’s) in support of deliverables based outsourced projects.
You are:
Education and Experience Requirements/Qualifications:
Considering the complexity of the tasks to be done, expectations are that the individuals assigned to provide the services will have the following skills:
All Levels:
- Bachelor’s degree or higher and / or equivalent in computer science, mathematics or other scientific field (or equivalent theoretical/technical depth).
- Demonstrated written and verbal communication.
- Ability to work remotely
- Knowledge of R is a plus
- Minimum 8+ years of experience, demonstrating increasing responsibilities.
- At least 2+ years of trial lead experience preferably as the lead for a team of programmers OR At least 2+ years of experience developing SAS/R solutions that are implemented broadly across clinical programs or a therapeutic area.
- Demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects.
- Ability to communicate with cross-functional teams and gather feedback for study specifications and/or data issues. Experience reviewing and writing data specifications.
- Experience working with CROs and reviewing work packages.
- High level experience in the implementation of SAS (Base and Macro) in the analysis of clinical trial data
- In-depth knowledge of clinical trial data (Study population, safety, efficacy, PK/PD) in the therapeutic are being serviced
- Demonstrated understanding of current industry standards for submission of clinical trial data
Why 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.
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.
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, colour, 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.
Interested 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.
