Datawise Inc · 13 hours ago
Contractor - Senior statistical programmer - Remote
United States
Contract
Remote
Senior Level
5+ years expDatawise Inc is a pharmaceutical company seeking a Senior Statistical Programmer to play a key role in the development, validation, and maintenance of clinical trial data analyses. This position involves ensuring compliance with CDISC standards and regulatory requirements while developing datasets and statistical programming deliverables for drug development and regulatory submissions.
Biotechnology
No H1B
Responsibilities
Develop and validate SDTM and ADaM datasets in accordance with CDISC standards
Generate high-quality tables, listings, and figures (TLFs) for clinical study reports and regulatory submissions
Ensure the accuracy, quality, and timeliness of statistical analyses and deliverables
Perform rigorous quality control (QC) checks on all programming outputs
Troubleshoot and resolve data and programming issues efficiently
Collaborate with cross-functional study teams to support accurate and consistent data reporting
Promote programming best practices by demonstrating strong technical expertise in statistical programming environments and tools
Lead, mentor, and provide guidance to junior programming staff, fostering technical and professional development
Ensure full compliance with regulatory submission requirements and CDISC standards (SDTM, ADaM)
Qualification
Required
Bachelor's or Master's degree in Statistics, Computer Science, or a related field
Minimum 5 years of relevant experience in the biopharmaceutical, biotechnology, or CRO industry
Proficiency in SAS programming
Hands-on experience with raw datasets, SDTM, and ADaM dataset development
Strong analytical, problem-solving, and communication skills (both verbal and written)
Ability to work effectively in a cross-functional, matrixed environment, proactively influencing teams with innovative clinical development strategies
Preferred
Experience in late-phase (phase III) trials is highly desirable
Familiarity with R is a plus
Prior NDA/BLA submission experience is a plus
Company
Datawise Inc
Drawing from years of clinical research expertise, our proficient professionals specialize in top-tier services including clinical study design, data management, statistical analysis, and SAS/statistical programming.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase