Monster

Senior/Principal Statistical Programmer, PK/PD

IQVIA

Baltimore, MD

JOB DETAILS
LOCATION
Baltimore, MD
POSTED
5 days ago
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 We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.
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.The potential base pay range for this role, when annualized, is $111,400.00 - $203,100.00.
The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).
Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.SummaryLocation: Durham, North Carolina, United States of America; Chicago, IL; Seattle , WA; Miami, FL; Charleston, SC; Phoenix, AZ; Charlotte, NC; Overland Park, KS; Cleveland, OH; New Haven, CT; Los Angeles, CA; Orlando, FL; Atlanta, GA; Kansas City, KS; Houston, TX; Richmond, VA; Philadelphia, PA; Baltimore, MD; Kansas City, MO; New York, NYType: Full time

About the Company

I

IQVIA

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. Healthcare is an industry designed to help humans. As a global community, we continuously invest and commit to advancing human health. To deliver value and real outcomes. To rise to the challenge to find the next breakthrough by making the most of increasingly limited resources. We are inspired by the potential and propelled by the possibilities. We share the vision to drive healthcare forward. To see how we can help accelerate progress and achievements. Others are developing these medical breakthroughs. We do our part by using breakthroughs in insights, technology and human intelligence to reimagine and deliver ways to help make them a reality. It’s bigger than better clinical trials. Or advances in technologies and analytics. Or faster insights. It’s about exploring a new path to better health outcomes via Human Data Science. It’s about harnessing the power of the IQVIA CORE™ to channel the insights, commercial and scientific depth, and executional expertise that drive maximum value for our customers. Motivated by the industry we help, we’re committed to providing solutions that enable life sciences companies to innovate with confidence, maximize opportunities, and, ultimately, drive human health outcomes forward.
COMPANY SIZE
10,000 employees or more
INDUSTRY
Healthcare Services
FOUNDED
1982
WEBSITE
https://www.iqvia.com/