Senior Biostatistical Programming

Overview

Overview

A global biopharmaceutical company on a mission to Solve On, Incyte follows science to find solutions for patients with unmet medical needs. Through the discovery, development, and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Hematology, Oncology and Inflammation and Autoimmunity

Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe, and Asia.

The job is based in Wilmington Delaware, US. (Minimum 3 days per week in the office. Local candidates or those willing to relocate only).

Job Summary (Primary function)

The Senior Biostatistical Programmer is responsible for processing clinical data required for statistical analysis of Phase I — III clinical trials.

Essential Functions of the Job (Key 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.
• Participate in TLF shell preparation and review, and assist statistician for SAP preparation.
• Run CDISC validation programs e.g. Pinnacle 21 reports to ensure ADaM datasets are CDISC compliant.
• Learn and implement Incyte standard SAS macros for efficient analyses of clinical data supervised by Lead programmers.
• Validate programs and associated results produced by other programming team members.
• Work independently to program for individual studies with minimum supervision.

• Ensure that validation summary reports are free of errors and warnings, and that they include proper documentation of SAS programs.
• Review individual study CDISC validation output.
• Exposure to R Programming

Qualifications (Minimal acceptable level of education, work experience, and competency)

• BA/BS degree in mathematics, statistics, computer science or health related field.
• Minimum of several years of programming experience using SAS/Base/Macro/GRAPH in the pharmaceutical industry.
• Good SAS programming skills and attention to details.
• Demonstrate knowledge of regulatory guidelines, including electronic submission standards.
• Strong organizational, time management, communication, project coordination, and leadership skills.
• Ability to work efficiently within compressed timelines is essential.
• Must be able to work on multiple tasks while coordinating others at the same time.
• Some exposure to R programming would be a plus.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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