Sr. Principal PKPD SAS programmer

Incyte Corporation; United States; Remote; USD 100,000 - 140,000; Full time

Job summary

A leading biopharmaceutical company seeks a Sr. Principal PK/PD SAS Programmer to manage Phase I–III clinical trial data. The ideal candidate will have extensive experience in SAS programming and a strong grasp of regulatory biostatistics to provide accurate analysis and project management. This role includes working with cross-functional teams and validating data processes to ensure compliance and data integrity.

Qualifications

• Demonstrated knowledge of regulatory biostatistics, SOPs, and guidelines.
• Experience in data management is valued, but not mandatory.
• Minimum of several years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO industries.

Responsibilities

• Work with Clinical Research Organizations to ensure programming activities are managed.
• Write statistical analysis plan and perform exposure-analysis on QTc.
• Generate PK/PD analysis data sets and provide summary tables using SAS.

Skills

Organizational skills

Time management

Project coordination

SAS programming

Attention to detail

Education

Bachelor's degree or equivalent experience

Job description

Overview

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

The Sr. Principal PK/PD SAS Programmer processes PK/PD data required for Phase I — III clinical trials, develops SAS macros to facilitate data management and analyses, and performs exposure-QTc analysis and exploratory statistical analyses on PK/PD relationship.

Responsibilities

• Work with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure timelines and deliverables are met. Assess data accuracy and consistency.
• Write statistical analysis plan and perform exposure-analysis on QTc as requested.
• Generate PK/PD analysis data sets and provide summary tables, graphs and data listings using SAS to support NCA or pop PK/PD analysis.
• Ensure that all programs, outputs and documentation are consistent with relevance.
• Design and implement statistical algorithms and code in conformance with defined programming processes and standard operating procedures.
• Interact with members of the multidisciplinary team to establish project timelines; computerized data validation checks and ad hoc requests.
• Develop standard SAS macros for efficient analyses of clinical data which will be validated and can be production use.
• Work independently to ensure the accuracy and quality of delivered results to satisfy the requirement of healthy authorities.

Qualifications

• Strong organizational, time management and project coordination skills.
• Motivated and able to work well independently or as part of a team.
• Demonstrated knowledge of regulatory biostatistics, SOPs, and guidelines.
• Proficiency in SAS programming and strong attention to detail are essential.
• Experience in data management is valued, but not mandatory.
• Minimum of several years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO industries, or equivalent skills and knowledge.
• Bachelor's degree or equivalent experience.

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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