Work with one of our preferred clients! Our client is a leading pharmaceutical/biotech company dedicated to advancing medical science and improving patient outcomes through the development of innovative therapeutics. Their research-driven organization focuses on discovering, developing, and commercializing novel drugs across various therapeutic areas. 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.

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.

Responsibilities:

- PK/PD Data Analysis: Conduct comprehensive PK/PD data analysis using appropriate statistical methodologies to support clinical trial designs and assist in decision-making processes.

- Statistical Programming: Develop and implement robust and efficient statistical programming solutions for analyzing PK/PD data, adhering to industry best practices and regulatory standards.

- Protocol Development: Provide valuable input during protocol development, ensuring proper incorporation of PK/PD endpoints and statistical methodologies.

- Clinical Trial Support: Collaborate with cross-functional teams to ensure the timely and accurate delivery of PK/PD data analysis for ongoing clinical trials, supporting data interpretation and presentation.

- Regulatory Submissions: Contribute to regulatory submissions by preparing and validating PK/PD datasets, analysis outputs, and documentation in compliance with relevant regulatory guidelines.

- Innovation and Methodology: Stay abreast of the latest developments in PK/PD methodologies, statistical programming techniques, and industry best practices, and apply them effectively to enhance drug development strategies.

- Process Improvement: Drive continuous improvement in statistical programming processes and contribute to the development of standard operating procedures (SOPs) to streamline PK/PD data analysis.

Qualifications:

• 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.

• Detail-oriented with a commitment to producing high-quality deliverables within tight timelines.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status