Clinical Data Management and Reports Programmer

Employment Type

: Full-Time

Industry

:



NYU School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu, and interact with us on Facebook, Twitter and Instagram.

Position Summary:
We have an exciting opportunity to join our team as a Clinical Data Management and Reports Programmer.

In this role, the successful candidate EPPIC-Net is a network that will include a Data Coordinating Center (DCC), Clinical Coordinating Center (CCC), and ten Specialized Clinical Centers (SCCs). The DCC will work with Federal government partners to conduct high-quality efficient clinical trials to develop non-addictive treatments for pain as part of the Helping to End Addiction Long-term (HEAL) initiative. The DCC will provide a range of coordinating services for this NIH-funded network, including statistical and data management; collection of clinical, biomarker and imaging data; and establishment of repositories for biospecimens and biomedical images.
The Clinical Data Management and Reports Programmer will work closely with the EPPIC-Net DCCs Principal Investigator, Data Management Leadership, and key stakeholders in developing comprehensive data validation specifications to review and edit each data element collected for completeness, timeliness, and accuracy. S/he will also support the Biostatistics team in producing study-specific reports in compliance with Data and Safety Monitoring Board requirements/guidelines.

Job Responsibilities:

  • Develop SAS programs to implement data validation specifications (e.g., required fields, range checks, data type checks, and within- and across-record logic checks); execute SAS validation programs (and edit them as necessary) each time data are added to the study database; collaborate with Clinical Data Manager and DCC personnel to identify additional validation requirements based on commonly identified issues and feedback from participating sites.
  • Develop SAS outlier programs to identify data that may exceed actual and logical limitations of each data element and produce reports specifying possible and probable errors contained in the data (e.g., invalid data, missing data, and data in conflict with the within- and across-record logic checks).
  • Assist in creating aggregated datasets; develop and execute ad hoc operational reports not already implemented within the EDC (e.g., nonstandard query reports).
  • Assist in production of the DSMB charter and development of DSMB and regulatory report specifications; develop SAS programs/routines to implement DSMB and regulatory report specifications and produce tables, listings, and figures (TLFs); develop programs to populate table shells for routine DSMB and regulatory reports; manage the development and implementation of validation procedures for routine reports and statistical analysis.

Minimum Qualifications:
To qualify you must have a Typically requires 4 or more years of experience and BA/BS degree or equivalent.

Preferred Qualifications:
In-depth understanding of data collection, data flow management, data quality, data extraction and data standards (knowledge of CDISC standards for CDASH, SDTM and ADaM a plus); Experience with multiple programming languages (SAS programming language, R, SQL or other languages/tools as required, SAS Certification desired), including the creation of data entry and query screens/processes and data quality checks

Qualified candidates must be able to effectively communicate with all levels of the organization.

NYU School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents.

NYU School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online.
If you wish to view NYU School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information. To view the Pay Transparency Notice, please click here.

Position Summary:
EPPIC-Net is a network that will include a Data Coordinating Center (DCC), Clinical Coordinating Center (CCC), and ten Specialized Clinical Centers (SCCs). The DCC will work with Federal government partners to conduct high-quality efficient clinical trials to develop non-addictive treatments for pain as part of the Helping to End Addiction Long-term (HEAL) initiative. The DCC will provide a range of coordinating services for this NIH-funded network, including statistical and data management; collection of clinical, biomarker and imaging data; and establishment of repositories for biospecimens and biomedical images.
The Clinical Data Management and Reports Programmer will work closely with the EPPIC-Net DCCs Principal Investigator, Data Management Leadership, and key stakeholders in developing comprehensive data validation specifications to review and edit each data element collected for completeness, timeliness, and accuracy. S/he will also support the Biostatistics team in producing study-specific reports in compliance with Data and Safety Monitoring Board requirements/guidelines.

Minimum Qualifications:
Typically requires 4 or more years of experience and BA/BS degree or equivalent.

Preferred Qualifications:
In-depth understanding of data collection, data flow management, data quality, data extraction and data standards (knowledge of CDISC standards for CDASH, SDTM and ADaM a plus); Experience with multiple programming languages (SAS programming language, R, SQL or other languages/tools as required, SAS Certification desired), including the creation of data entry and query screens/processes and data quality checks


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