Incyte · 2 weeks ago
Biostatistical Programmer to Principal Biostatistical Programmer
Wilmington, DE
Full-time
Onsite
Mid, Senior Level, Lead/Staff
4+ years expIncyte is a biopharmaceutical company focused on innovative medicines for oncology and inflammation. The Biostatistical Programmer to Principal Biostatistical Programmer will process clinical data for statistical analysis of clinical trials and lead project teams, ensuring compliance with regulatory guidelines.
BiotechnologyHealth CareMedicalMedical DevicePharmaceutical
Responsibilities
Conduct statistical programming work of clinical data using SAS Software
Ensure that all programs, outputs and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs
Generate analysis datasets according to CDISC standard and SAP
Implement analysis methods according to SAP, and produce summary tables, graphs and data listings using SAS; Conduct ad hoc analyses
Validate programs and associated results produced by other programming team members
Participate in TLF shell preparation and review, and assist statistician for SAP preparation
Run CDISC validation programs e.g. OpenCDISC reports to ensure ADaM datasets are CDISC compliant
Develop standard SAS macros for efficient analyses of clinical data under the guidance of Programming management
Participate in the review of 'Statistical Analysis Plan' and other documents essential to the conduct of statistical programming work for clinical trials
Collaborate with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure quality, timelines, and deliverables are met. Work independently to program for individual studies with minimal supervision
Work independently to program for individual studies with minimum supervision
Function as a Lead programmer for a project or a group of studies performing the following functions: Maintain the overall timeline for their studies. Maintain the programming standards for their studies. Review standard macros used. Review standard datasets used. Discuss the need for programming resources for the group of studies. Guide and support team members on Incyte systems and standards as they work on studies within their area. Assist less experienced programmers in new study set-up to help identify similar studies. Review Production area after study programming is complete to make sure datasets, programs, and outputs are properly stored. Check that the validation summary reports are clean of errors and warnings, and show proper documentation of SAS programs. Review individual study CDISC validation output
Act as a Programming lead for a submission project under supervision of Programming management
Serve as a mentor to less experienced programmers and as an expert to provide recommendations and solutions to complex problems
Qualification
Required
Strong organizational, time management, communication and project coordination and leadership skills
Demonstrate knowledge of regulatory guidelines, including electronic submission standards
Good SAS programming skills and attention to detail are essential
Minimum of several years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO industries, or equivalent skills and knowledge
Demonstrate experience in mentoring team members and providing expert recommendations and solutions to complex problems
Must be able to manage multiple tasks while collaborating with team members effectively
Must be able to effectively manage workload and prioritize tasks in a dynamic environment
Preferred
Experience with data management, including familiarity with CDISC standards, is highly desirable
A degree in a relevant field such as statistics or computer sciences is preferred, but equivalent practical experience will also be considered
Company
Incyte
Incyte is a drug discovery and development company which hopes to build a proprietary product pipeline of novel small molecule drugs.
1001-5000 employees
H1B Sponsorship
Incyte has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (34)
2023 (32)
2022 (39)
2021 (36)
2020 (24)
Funding
Current Stage
Public CompanyTotal Funding
unknown1996-01-16IPO
Leadership Team
Bill Meury
President & CEO
Jim Lee
Group Vice President, Head Inflammation and AutoImmunity Group
Recent News
2026-01-07
2026-01-06
Clinical Trials Arena
2026-01-06
Company data provided by crunchbase