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This position involves project management for the statistical analyses and programming of clinical trials from small investigator initiated studies to large scale international clinical trials.
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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.
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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.
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Substantial experience in statistical programming using SAS, R, or other relevant programming languages within the pharmaceutical or biotech industry. 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.
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The Statistical Analyst A will use standard SAS and/or STATA programming skills to create analytical datasets from clinical trials, surveys, and health care claims, to construct and standardize outcome measures and other analytical variables through data cleaning and data manipulation, to provide descriptive and analytical reports, and to perform specialized statistical analyses.
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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. Solid understanding of clinical trial designs, protocols, and regulatory requirements related to PK/PD endpoints.
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Master's or Ph. D. in Biostatistics, Statistics, or a related field with a strong emphasis on pharmacokinetics (PK) and pharmacodynamics (PD) tables within tight timelines. Familiarity with industry standards such as CDISC data structures and guidelines for data submissions.
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Qualifications:Substantial experience in statistical programming using SAS, R, or other relevant programming languages within the pharmaceutical or biotech industry. Qualifications:Substantial experience in statistical programming using SAS, R, or other relevant programming languages within the pharmaceutical or biotech industry.
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Proven expertise in PK/PD data analysis and interpretation, including modeling and simulation. 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.
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Detail-oriented with a commitment to producing high-quality deliverMaster's or Ph. D. in Biostatistics, Statistics, or a related field with a strong emphasis on pharmacokinetics (PK) and pharmacodynamics (PD) tables within tight timelines.
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We are seeking an exceptional Senior Principal Statistician with strong statistical and computational skills to support multiple complex clinical trials in Oncology and COVID. The Senior Principal Statistician is responsible for leading and performing biostatistics and statistical programming activities in these trials, which may be Phase I, II and III pharmaceutical trials and medical device trials evaluating new biomarkers and/or therapeutics.
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The Programmer Analyst II will provide statistical support for new and ongoing HIV and other emerging infectious disease studies conducted by MHRP, EIDB, and affiliated programs, involving clinical observational research, laboratory research, clinical trials, and other research studies.
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Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc.
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Minimum of 5 years of experience in developing statistical programming deliverables for clinical trials using the SAS system. Lead statistical programming activities as product lead for full development project or groups of projects in Oncology Therapeutics.
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Specializes in the clinical domain and works across biostatistics, clinical trials/research, data management, health economics/RWE, medical affairs, statistical programming, and other R&D areas within pharma and biotech.
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