Senior Statistical Programmer

NMDP•Minneapolis, MN

21h

About The Position

POSITION SUMMARY: The Center for International Blood and Marrow Transplant Research (CIBMTR) and the Clinical Research Organization (CRO) Services team provides a unique resource of data and statistical expertise to the scientific community for addressing important issues in hematopoietic cell transplantation and cellular therapies space. This role participates in the statistical support of clinical trial and observational research studies that further the mission, vision and strategic plan of NMDP. This role actively participates in the statistical programming support of research studies that further the mission, vision and strategic plan of NMDP. In addition to contributing their time programming, this role will mentor and train other programming staff (statistical programmers and biostatisticians) on programming deliverables and programming topics. ACCOUNTABILITIES: Technical Accountabilities 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. General Accountabilities Understand timelines and milestones affecting work. Follow the department and company standard operating procedures (SOPs), policies, and standards. Provide excellent customer service to internal teams and external clients in a timely and professional manner. Respond to email and other communications in a timely fashion using a variety of methods. Complete project-specific responsibilities with minimal supervision or reminders. Leadership Accountabilities 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).
Bachelor’s degree or Master’s degree in: o programming, statistics, computer science, math, health-related sciences or other relevant field o 8+ years’ experience with Bachelor’s o 5+ years’ experience with Master’s

Nice To Haves

Experience working on Phase I/II/III clinical trials.
Experience in oncology therapeutic space.

Responsibilities

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.
Understand timelines and milestones affecting work.
Follow the department and company standard operating procedures (SOPs), policies, and standards.
Provide excellent customer service to internal teams and external clients in a timely and professional manner.
Respond to email and other communications in a timely fashion using a variety of methods.
Complete project-specific responsibilities with minimal supervision or reminders.
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.