Clinical SDTM Programmer

KCR Placement is a full-service functional sourcing and recruitment provider. As part of the ICON organization, we specialize in high-speed and high-quality talent sourcing for the CRO, Pharmaceutical, Biotech and Medical Device industries across Europe.

Our employees are KCR Placement's most crucial asset. We commit to placing our candidates at the center of all we do and prepare them for long-term career development and success with competitive benefits and vibrant work environment. The KCR Placement team is supported by a specialized referral network of expert professionals and is dedicated to providing sourcing services and client support from job requisition to job offer.

Clinical SDTM Programmer 

Location: EMEA (remote)

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

Duties associated with the role include:

• Interact with vendors to receive CRF & external data. Review data transfer specs to ensure data is in a form we can use (SAS compliant variable names, follow Client standards and specific compound templates, file format is something we can use with little manipulation).
• Review CRF & external data received. Compare datasets and vendor annotated CRF to ensure all expect fields are captured – these datasets are then used to build the SDTM datasets.
• Write SAS programs to compare CRF data and External data (LAB, ECG, PK, EEG) – compare subject id, visit, date, time, accession number. Reports are then given to data managers for reconciliation and to issue queries.
• Create Trial Design Domains based on protocol/CRF.
• Use a GUI interface (DSP) to create SDTM datasets. Using a series of boxes following arrows across the screen to layout the flow of data and the computations needed.
• This is “SAS-like” but is not using SAS directly to program the SDTM datasets. When you execute what is created in GUI environment, the system then writes SAS code to build the datasets. Takes some detective work to figure out what went wrong by looking at temporary and output datasets, and behind-the-scenes SAS code that gets written.
• Create SDRG and SDTM define
• QC SDTM datasets, specs, docs, annotations that other programmers create.
• Troubleshooting and SAS programming to create tools for the team – such as create a SAS programs to convert .csv/.xlsx/.dat files to SAS datasets. Or create programs to do full Proc Compare of a study’s database (new data versus old data) that can be used as a standard across studies.
• Interacting with data managers, clinical programmers, statisticians, medical coders, external data vendors.
• Running Pinnacle 21 to validate SDTM datasets

Requirements:

• Having minimum 5+ years of experience with SDTM
• 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.
• Having demonstrated organizational and leadership skills to handle multiple competing priorities simultaneously across projects.
• Having ability to communicate with cross-functional teams and gather feedback for study specifications and/or data issues. Experience reviewing and writing data specifications.
• Experienced working with CROs and reviewing work packages.
• Having high level experience in the implementation of SAS (Base and Macro) in the analysis of clinical trial data

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 maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Program, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others

Our Privacy Policy

As KCR became part of the ICON group, your personal data will be shared with ICON and processed in accordance with privacy notice: https://www.iconplc.com/privacy/job-applicants

If you want your candidacy to be considered also for future recruitments, please send us an additional consent: “I agree to the processing of my personal data for any future recruitments conducted by ICON”. Such consent may be placed in your CV or electronic correspondence addressed to us. You can withdraw your consent at any time. Withdrawal of consent does not affect the legality of the processing carried out prior to its withdrawal.

KCR is an equal opportunity employer. In line with our motto, ‘We see human behind every number,’ KCR is committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all.

We are committed to non-discriminatory practices and provide an equal opportunity for all qualified employees and job applicants within all employment sectors. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.