Senior Biostatistical Programmer

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)

The Senior Biostatistical Programmer is responsible for processing clinical data required for the 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. Open DISC 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 colleagues.

* 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.

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

* BA/BS degree in mathematics, statistics, computer science or health related field.

* 4 - 8 years of SAS programming working experience in the pharmaceutical industry.

* Good SAS programming skills and attention to details

* Demonstrated knowledge of regulatory guidelines, including electronic submission standards.

* Strong organizational, time management, communication, and 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.

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.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

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