Principal Statistical Programmer, PKPD

3 weeks ago


Durham, North Carolina, United States IQVIA Full time

We are seeking a highly skilled and motivated Principal Statistical Programmer with expertise in pharmacokinetics (PK) and pharmacodynamics (PD) to join our dynamic team.


Position Overview:

As a Principal Statistical Programmer with a specialized focus on PK/PD, you will play a pivotal role in the design, execution, and analysis of clinical trials to support the development of our promising drug candidates.

Leveraging your extensive knowledge of statistical programming and PK/PD principles, you will collaborate closely with cross-functional teams of scientists, clinical researchers, and biostatisticians to ensure the successful implementation of our clinical development programs.


Key Responsibilities:
Develop and implement statistical analysis plans for clinical trials.
Design and execute PK/PD models and simulations to support drug development.
Collaborate with cross-functional teams to ensure successful implementation of clinical development programs.
Provide expert statistical programming and PK/PD analysis to support regulatory submissions.

Requirements:
Master's or Ph.D. in Biostatistics, Statistics, or a related field with a strong emphasis on pharmacokinetics (PK) and pharmacodynamics (PD).
Substantial experience in statistical programming using SAS, R, or other relevant programming languages within the pharmaceutical or biotech industry.
Proven expertise in PK/PD data analysis and interpretation, including modeling and simulation.
Solid understanding of clinical trial designs, protocols, and regulatory requirements related to PK/PD endpoints.
Familiarity with industry standards such as CDISC data structures and guidelines for data submissions.
Strong analytical, problem-solving, and communication skills, with the ability to work effectively in cross-functional teams.

About IQVIA:

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.

We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.



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