Statistical Programmer II

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Job Title: Statistical Programmer II

Location : Chennai/ Bangalore/ Trivandrum

Responsibilities

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 J&J specifications• Creation of Subject Narratives following J&J templates to 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.

• High level experience in the implementation of SAS (Base and Macro) in the analysis of clinical trial data• Working 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.

Qualifications

You are:

• Bachelor’s degree or higher and / or equivalent in computer science, mathematics, or other scientific field (or equivalent theoretical/technical depth).
• Advanced degree (Master's, PhD or equivalent) preferred for Level 4.
• Demonstrated written and verbal communication
• Minimum 4+ years of experience

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.