Statistical Programmer

Senior Statistical Programmer (SDTM)

Location: Bangalore, Home based

As a Statistical Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

This role will not have any exposure to ADaM or TLFs. 

What you will be doing:

• Perform programming to convert raw, clinical trial data to Study Data Tabulation Model (SDTM) format (annotating the CRF, building mapping specifications and programming)
• 90% SDTM and 10% on Report programming
• Perform Quality Control (QC) on programming work performed by fellow programmers.
• Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency.
• Perform consistency checks on data transferred between sponsor and external parties to ensure completeness and accuracy of data contained transfers.
• Develop transfer specifications with vendors for external data sources.
• Extract clinical data from the clinical data management system and produce standard and custom reports, primarily in SAS.
• Program reports and listings as requested by project team members for ongoing studies

You are:

• Having Bachelor’s degree OR certification.
• Having minimum of 5 years of clinical SAS programming experience in the pharmaceutical industry. (Oncology experience is required)
• Hands-on experience in Define.xml, P21, SDRG.
• Having working knowledge of CDISC SDTM mapping/specs/conversion/domains/datasets/eCRF/ eCRT
• Experienced in Package/define.xml development and SDTM data transfer operations on clinical studies.
• Having understanding of regulatory requirements relevant to submissions.
• Knowledgeable of clinical trial study design and electronic data submission requirements.
• Having communication and interpersonal skills and the ability to work effectively as part of a team

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, 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-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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