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Senior/Principal Statistical Programmer

1 month ago

Blue Bell, United States DuBu Research Full time

About DuBu Research

DuBu Research (“DuBu”) is a biometrics-focused contract research organization (CRO) providing a range of expertise-based statistical services to biotech companies and CRO partners. Our services include study level SAP/Shell/SDTM/ADaM/TLF, study design, protocol development, randomization, data visualization, and DMC/DSMB support.


Position

Senior Statistical Programmer / Principal Statistical Programmer


Department

Biostatistics


Description

A Senior/Principal Statistical Programmer performs advanced programming activities for the statistical and computational considerations of projects, works in a lead programmer role on select moderately complex studies, and provides training and guidance to junior team members.


Responsibilities

· Annotates Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.

· Develops SDTM specifications and generates SDTM datasets using SAS.

· Develops ADaM, specifications and generates ADaM datasets using SAS based on Statistical Analysis Plan.

· Develops Tables, Listings, Graphs, and Patient Profiles in support of the Clinical Study Report, Posters, and Manuscripts.

· Develops ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).

· Creates electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines.

· Analyzes information and develops innovative solutions to programming and data analysis challenges.

· Actively communicates with statisticians for statistical input and analysis interpretation.

· Follows and reinforces regulatory agency requirements during daily job.

· Serves as a programming team lead and contributes to department initiative.

· Provide guidance, mentoring, and training for team members and helps solve issues from cross-functional teams.

· Reviews draft and final production deliverables for project to ensure quality and consistency.


Qualifications

· Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, or related scientific disciplines that provides computer literacy and numeracy, and 3 years of clinical programming experience for Senior Statistical Programmer or 6 years of clinical programming experience for Principal Statistical Programmer

· Advanced SAS programming skills with expert knowledge in SAS/Macro, Proc Report and ODS. Good working knowledge in SAS/Graph, Proc SQL, SAS/STAT.

· Proficient in decoding programming logic and assembling programming code based on logic provided and able to explain to team members.

· In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.

· Proficient in Microsoft Office Suite including Word, Excel, and PowerPoint.

· Strong communication skills and coordination skills, ability to communicate with cross-functional or global teams.

· Detail oriented and ability to learn and adapt to changes.