Statistical Programmer II

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 (SDTM)

Location : Chennai/ Bangalore/ Trivandrum

What you will be doing:

• Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc.

• Review and provide input into all trial set-up documentation

• Translate protocol and any applicable de-risking into the creation and maintenance of detailed technical specifications, mapping documentation including aCRF, data transfer agreements, as applicable, etc.

• Creation of Data Review Model (DRM) based on current standards and SDTM datasets based on current SDTM standards

• Creation of back-end edit checks, listings, and visualizations to support risk-based central monitoring, e.g., Quality Tolerance Limits (QTLs), Critical to Quality (CtQ), etc., and ongoing clinical and safety data review

• QC of all clinical programming deliverables

• Perform unblinding, data-cut activities for planned reporting milestones and database locks

• Development and validation of electronic submission packages that comply with submission requirements from FDA, EMEA, and other regulatory agencies as needed.

• Support the development of standards and drive implementation within the organization

You are:

• Minimum 4+ years of experience
• In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e., SAS, SQL, Python, R, etc.)
• Strong knowledge of complex finding data types, including but not limited to biomarkers, and digital data such as ECG, imaging, etc.
• In-depth knowledge of SDTM including Define.xml, CDASH, and metadata as well as experience transforming transferred vendor data into SDTM preferred, knowledge of AdaM a plus
• Experience utilizing tools intended for report writing, analytics, visualizations, or dashboard creation (e.g., Spotfire, Tableau, Qlik, JReview, Business Objects, Oracle BI, etc.) to support ongoing clinical data and safety review

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/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. 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-accommodations

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.

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