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Katalyst Healthcares & Life Sciences

Senior/Principal Statistical Programmer, PK/PD

Katalyst Healthcares & Life Sciences, Durham, North Carolina, United States, 27703


Responsibilities:

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.

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 modelling 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.

Detail-oriented with a commitment to producing high-quality deliverables.

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

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