Senior Biostatistical Programming

Incyte Corporation•Wilmington, DE

5d•Hybrid

About The Position

The Senior Biostatistical Programmer processes clinical data for statistical analysis of Phase I–III clinical trials. The role uses SAS to generate analysis datasets and statistical outputs in accordance with CDISC standards, Statistical Analysis Plans (SAPs), ICH guidelines, and company standard operating procedures. The programmer also supports TLF shell preparation and review, assists statisticians with SAP preparation, validates programs and results, and reviews CDISC validation outputs. The position is based in Wilmington, Delaware, and requires working in the office at least three days per week; local candidates or candidates willing to relocate are considered.

Requirements

Bachelor’s degree in mathematics, statistics, computer science, or a health-related field.
Several years of SAS/Base/Macro/GRAPH programming experience in the pharmaceutical industry.
Good SAS programming skills and attention to detail.
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.
Ability to work on multiple tasks while coordinating others at the same time.

Nice To Haves

Some exposure to R programming.

Responsibilities

Conduct statistical programming of clinical data using SAS software.
Ensure programs, outputs, and documentation are consistent with ICH guidelines and comply with company SOPs.
Generate analysis datasets according to CDISC standards and the SAP.
Implement analysis methods according to the SAP and produce summary tables, graphs, and data listings using SAS; conduct ad hoc analyses.
Participate in TLF shell preparation and review, and assist statisticians with SAP preparation.
Run CDISC validation programs, such as Pinnacle 21 reports, to ensure ADaM datasets are CDISC-compliant.
Learn and implement Incyte standard SAS macros for efficient clinical data analyses under the supervision of lead programmers.
Validate programs and associated results produced by other programming team members.
Program independently for individual studies with minimal supervision.
Ensure validation summary reports are free of errors and warnings and include appropriate SAS program documentation.
Review individual study CDISC validation output.