Job Description

Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization. Wexe2x80x99re 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:

• Bachelorxe2x80x99s 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. Thatxe2x80x99s why wexe2x80x99ve 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 familyxe2x80x99s 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 familyxe2x80x99s 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/benefits
At 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 wexe2x80x99ve done to become a more inclusive organisation. Wexe2x80x99re 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-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless xe2x80x93 therexe2x80x99s every chance youxe2x80x99re exactly what wexe2x80x99re looking for here at ICON whether it is for this or other roles. '