Sr. Principal PKPD SAS programmer

InCyte • Wilmington, DE

57d

About The Position

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 (Primary function) The Sr. Principal PK/PD SAS Programmer provides PKPD programming aspects of pharmacokinetics, pharmacodynamics data management by timely completion and high quality of all required deliverables.

Requirements

• BS, MSc, Master in Statistics, Mathematics, PhD, PharmD, or related fields.
• About 5 years' experience and expertise in PKPD programming and analysis, report writing, and regulatory drug submissions.
• General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology.
• Expertise in PK/PD programming with strong quantitative skills applied to develop PPK, PKPD, ER-efficacy, ER-safety, and C-QTc datasets.
• Expertise in software used for dataset construction (e.g. R, SAS).
• Strong track record of working in various therapeutic areas.
• Familiarity with regulatory requirements and trends with respect to data standards.

Responsibilities

• Prepare data for state-of-the-art analysis, such as PPK, PKPD, exposure-response (efficacy or safety), and C-QTc, typically based on CDISC ADaM / SDTM datasets.
• Prepare data for state-of-the-art NCA analysis, such as ADPC, PP, and ADPP, including the creation of defined packages and reviewer guides.
• Write, maintain, and develop high-quality Programs and Macros (R, SAS) to facilitate the construction of analysis datasets and P21 validations.
• Interact with members of the multidisciplinary team to establish project timelines; computerized data validation checks and ad hoc requests.
• Design and implement statistical algorithms and code in conformance with defined programming processes and standard operating procedures.
• Conduct exploratory analyses of PKPD data in support of modeling analyses.
• Write statistical analysis plan and perform exposure-analysis on QTc as requested.
• Following completion of the project deliverables, you are responsible for the creation of an electronic submission package for future submission to regulatory agencies.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree
• Number of Employees: 1,001-5,000 employees