Piper Companies
ADaM Data Standards Engineer (Remote)
Piper Companies, Raleigh, North Carolina, United States, 27601
Piper Companies
is searching for an experienced
ADaM Data Standards Engineer
to join a global leader in clinical research and healthcare analysis for a
remote position . The
ADaM Data Standards Engineer
is focused on ADaM Oncology standards and does
not
involve study-level programming. The ideal candidate will have recent solid tumor experience and a strong background in ADaM and SDTM standards, with the ability to lead cross-functional initiatives and working groups.
Responsibilities
Lead the development and maintenance of ADaM Oncology Mapping Specifications and Implementation Guides.
Serve as the primary contact for Statistical Programmers on Oncology studies, providing expert guidance on ADaM mappings.
Conduct impact assessments of changes to Oncology collection forms, SDTM updates, and TFL standards.
Represent ADaM data standards in cross-functional working groups (e.g., TFL, SDTM, GLIB Oncology Standards WGs).
Participate in preparing e‑submission packages and support strategic initiatives across therapeutic areas.
Qualifications
Bachelor’s or Master’s degree in Biostatistics, Computer Science, or related field.
Minimum of 5 years (BS) or 3 years (MS) of experience in statistical programming, with recent solid tumor oncology exposure.
Deep understanding of CDISC ADaM and SDTM standards and regulatory requirements (FDA, PMDA, EMA).
Experience with tools/platforms for SDTM and ADaM mapping and e‑submission preparation.
Strong communication, problem‑solving, and cross‑functional collaboration skills; ability to work independently.
Compensation
Salary Range:
$150,000-$170,000 USD/year
Comprehensive Benefits:
Medical, Dental, Vision, PTO & sick leave if required by law, and 401K
This job opens for applications on 10/16/25. Applications for this job will be accepted for at least 30 days from the posting date.
ADaM standards, SDTM standards, CDISC, solid tumor oncology, statistical programmer, SAS programming, e‑submission, FDA submission, PMDA submission, EMA submission, oncology data standards, clinical data standards, mapping specifications, implementation guide, regulatory data submission, clinical trials, biometrics, non‑study programming, oncology working group, TFL standards, clinical data science, biostatistics, remote statistical programmer, ADaM mapping, oncology ADaM, data standardization, clinical development, regulatory affairs, Gilead, macro development, cross‑functional collaboration
#LI-PB2 #LI-REMOTE
#J-18808-Ljbffr
is searching for an experienced
ADaM Data Standards Engineer
to join a global leader in clinical research and healthcare analysis for a
remote position . The
ADaM Data Standards Engineer
is focused on ADaM Oncology standards and does
not
involve study-level programming. The ideal candidate will have recent solid tumor experience and a strong background in ADaM and SDTM standards, with the ability to lead cross-functional initiatives and working groups.
Responsibilities
Lead the development and maintenance of ADaM Oncology Mapping Specifications and Implementation Guides.
Serve as the primary contact for Statistical Programmers on Oncology studies, providing expert guidance on ADaM mappings.
Conduct impact assessments of changes to Oncology collection forms, SDTM updates, and TFL standards.
Represent ADaM data standards in cross-functional working groups (e.g., TFL, SDTM, GLIB Oncology Standards WGs).
Participate in preparing e‑submission packages and support strategic initiatives across therapeutic areas.
Qualifications
Bachelor’s or Master’s degree in Biostatistics, Computer Science, or related field.
Minimum of 5 years (BS) or 3 years (MS) of experience in statistical programming, with recent solid tumor oncology exposure.
Deep understanding of CDISC ADaM and SDTM standards and regulatory requirements (FDA, PMDA, EMA).
Experience with tools/platforms for SDTM and ADaM mapping and e‑submission preparation.
Strong communication, problem‑solving, and cross‑functional collaboration skills; ability to work independently.
Compensation
Salary Range:
$150,000-$170,000 USD/year
Comprehensive Benefits:
Medical, Dental, Vision, PTO & sick leave if required by law, and 401K
This job opens for applications on 10/16/25. Applications for this job will be accepted for at least 30 days from the posting date.
ADaM standards, SDTM standards, CDISC, solid tumor oncology, statistical programmer, SAS programming, e‑submission, FDA submission, PMDA submission, EMA submission, oncology data standards, clinical data standards, mapping specifications, implementation guide, regulatory data submission, clinical trials, biometrics, non‑study programming, oncology working group, TFL standards, clinical data science, biostatistics, remote statistical programmer, ADaM mapping, oncology ADaM, data standardization, clinical development, regulatory affairs, Gilead, macro development, cross‑functional collaboration
#LI-PB2 #LI-REMOTE
#J-18808-Ljbffr