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Principal Statistical Programmer, PKPD

1 month ago


Durham, North Carolina, United States IQVIA Full time
Job Title: Principal Statistical Programmer, PKPD

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

Job Summary:

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.

Key Responsibilities:
  • Collaborate closely with cross-functional teams of scientists, clinical researchers, and biostatisticians to ensure the successful implementation of our clinical development programs.
  • Leverage your extensive knowledge of statistical programming and PK/PD principles to design, execute, and analyze clinical trials.
  • Develop and maintain complex statistical models and simulations to support PK/PD data analysis and interpretation.
  • Ensure compliance with industry standards, such as CDISC data structures and guidelines for data submissions.
  • Communicate effectively with stakeholders to ensure timely and accurate delivery of high-quality results.
Requirements:
  • 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.
Education:

Master's or Ph.D. in Biostatistics, Statistics, or a related field with a strong emphasis on pharmacokinetics (PK) and pharmacodynamics (PD).

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.