NMDP

Senior Statistical Programmer

NMDP

full-time

Posted on:

Location Type: Remote

Location: Minnesota • United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Create SDTM mapping specifications and ADaM data specifications. Perform quality control (QC) review of these documents prepared by others.
  • Create SDTM and ADaM define.xml files. Perform QC review of these files prepared by others.
  • Use SAS/R to develop final analysis datasets such as datasets per SDTM and ADaM specifications.
  • Program analysis deliverables such as tables, listings, and figures (TLFs) as specified in the study-specific statistical analysis plan (SAP), with oversight by Study Statistician(s) or Senior Programmer.
  • Collaborate with the Study Statistician(s) to resolve any study-related questions to ensure the programming outputs appropriately reflect the statistical analysis plans (SAP).
  • Complete programming in accordance with common industry standards and conventions, statistical requirements and specifications, and/or clinical trial sponsor’s requirements.
  • Generate complete and efficient analysis data models following approved dataset designs or specifications.
  • Perform validation by acting as double programmer or independent reviewer of analysis datasets and/or statistical output reports generated by other programmers or statisticians.
  • Develop programming codes and generate complete and accurate statistical output reports in well-defined formats.
  • Develop programs for centralized statistical monitoring or ongoing data review.
  • Document data and programming information in accordance with SOPs and guidelines.
  • Ensure high quality documentation of codes and programs via meticulous organization of codes and documentation.
  • Continuously review programs and code to identify errors, potential corrections, enhancements or system environment changes.
  • Use SAS to perform SDTM, ADaM, and table, listing, and figure (TLF) programming, validation and quality control (QC) review.
  • Archive clinical trial data (study data tabulation models and analysis data models) and programming information.
  • Identify growth areas for the team and present ideas for process improvements to leader(s).
  • Proactive contribution to continuous improvement of statistical programming processes and procedures through development of standards, macros, trainings, resources and documentation for the team.
  • Educate, train and mentor junior programmers and less experienced statistician team members with technical programming guidance.
  • Review the programming work of other team members via validation and ad hoc review.

Requirements

  • Proficiency of both R and SAS.
  • Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation.
  • Hands on experience programming within clinical trials and with SDTM/ADaM specifications and programming.
  • Experience with the following SAS concepts: Data Step Manipulation, Merge, Sort, Transpose, Reporting (Proc Report), Comparison (Proc Compare), Error Checking (Log resolution), modeling, missing data handling approaches/procedures, figure development.
  • Experience developing custom SAS macros and R functions.
  • Experience with P21 reporting and DEFINE, SDRG, ADRG development.
  • Base or Advance SAS certification preferred.
  • In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Experience and knowledge of clinical data management processes and tools (Medidata Rave and Veeva preferred).
  • Occasional overnight travel (2 times/year on average).
Benefits
  • NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits.
  • Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SASRSDTMADaMprogrammingdata manipulationcustom SAS macrosstatistical output reportsdata validationclinical trial programming
Soft Skills
collaborationmentoringprocess improvementattention to detailorganizationcommunicationproblem-solvingtrainingleadershipquality control
Certifications
Base SAS certificationAdvanced SAS certification