PK/PD jobs for research scientists at Certara

At Certara, we're committed to improving human health by offering a broad spectrum of software products and services, with special focus on supporting translational approaches to drug development. Our success depends on people who are bright, hard-working, and innovative. Certara operates from its headquarters in Princeton, New Jersey, USA with additional US offices in California, Missouri, and North Carolina, and international offices in France, Germany, the United Kingdom, China, India, and Japan. Certara offers a full range of competitive benefits. We currently have job openings for the following positions: Sr. Research Scientist http://www.certara.com/about-us/careers/sr.-research-scientist-product-champion-pharsight-software Location: Cary, NC Reports to: Director, Product Development The position requires a sound understanding of pharmacometrics with statistical background. Ideally, experience in clinical trial design, adaptive design, and enrichment design are desirable. Experience in pediatric trial design will be a plus. This position does not require laboratory or clinical work. The successful applicant needs to be self-motivated, able to do independent research and development, and excel in a team environment. Clear communication skills are essential. The successful applicant will join an internationally recognized, multidisciplinary team and will have the opportunity to further develop their knowledge and skills in the area of pharmacometrics and systems pharmacology Key Responsibilities: * Prototyping new statistical algorithms and new applications of current methods as solutions for pharmaceutical industry problems in the PK/PD, bioequivalence assessment and related areas. * Creating clinical trial simulation examples from both Phoenix NLME and NONMEM with R Script * Building various PK-PD models and collecting population/disease data/models for validation of Pharsight drug clinical development tools * Testing and prototyping of software products to review existing problems and propose solutions. * Collating and reviewing PK-PD models and data from the scientific literature * Recording and mathematically and statistically manipulating information accurately * Providing on-going customer support, education and training related to the documentation and use of Phoenix WinNonlin, Phoenix NLME, IVIVC, Trial Simulator, etc. * Acting as a tutor for workshops * Participating and representing the company in the pharmacometric community through meeting attendance (including formal written and oral presentations) and contributing to pharmacometric literature * Staying up-to-date with new technology and developments (e.g., FDA Guidance) in order to be positioned to recognize emerging opportunities * Participating in writing scientific reports relevant to projects at work * Working with projects to review existing problems and propose solutions * Supporting the implementation of new software development processes and technologies as well as improvements to current practices * Helping to shape future product features and functionality Qualifications: * Ph.D. degree in a specialty area such as PKPD/Pharmacometrics with a background in Statistics, Computational/Systems Biology, System Control or Bioengineering, Mathematics or a related discipline * 5-10 years of industry/consulting experience (may be combined with academic research) Skills & Abilities: * Well-developed work plan writing skills. Excellent writing, editing, verbal communication, and interpersonal skills * Ability to simultaneously manage multiple projects * Independent performance of analysis and modeling with little to no supervision and development of reports with minimal modifications required upon review * Demonstrable communication skills, as evident by presentation at scientific meetings, and good interpersonal and organizational skills * Proficiency in PK/PD software with at least one of the following software packages: WinNonlin, Phoenix NLME, Adapt, NONMEM, WinBUGS, MONOLIX or any other commonly used PK/PD tool; mathematical analysis/simulation platforms such as Matlab, acslX; statistical software such as S-PLUS/R/SAS * Proficiency in modeling (e.g., PK and PK/PD analyses, dose-response and exposure-response analyses, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling) * Knowledge of PK/PD properties of small and large molecules, pediatric drug development, * Knowledge of software development processes and principles of software design * Knowledge of parallel programming techniques such as MPI and OpenMP -------------------------------------------------------------------------------------------------------------------------------------------------------- Research Scientist http://www.certara.com/about-us/careers/research-assistant-research-scientist/research-scientist-software-development Location: Cary, NC Reports to: Director, Product Management The position requires a sound understanding of pharmacometrics and systems pharmacology. In addition, familiarity with protocols related to the conduct of clinical studies in children and adults are desirable. This position does not require laboratory or clinical work. The successful applicant needs to be self-motivated, able to do independent research and development, and excel in a team environment. Clear communication skills are essential. The successful applicant will join an internationally recognized, multidisciplinary team and will have the opportunity to further develop their knowledge and skills in the area of pharmacometrics and systems pharmacology. Responsibilities: * Building various PK-PD models and collecting population/disease data/models for validation of Pharsight drug clinical development tools. * Testing and prototyping of software products to review existing problems and propose solutions. * Collating and reviewing PK-PD models and data from the scientific literature. * Recording and mathematically and statistically manipulating information accurately. * Providing on-going customer support, education and training related to the documentation and use of Phoenix WinNonlin, Phoenix NLME, IVIVC, Trial Simulator, etc. * Acting as a tutor for workshops. * Participating and representing the company in the pharmacometric community through meeting attendance (including formal written and oral presentations) and contributing to pharmacometric literature. * Staying up-to-date with new technology and developments (e.g., FDA Guidance) in order to be positioned to recognize emerging opportunities. * Participating in writing scientific reports relevant to projects at work. * Working with projects to review existing problems and propose solutions. * Supporting the implementation of new software development processes and technologies as well as improvements to current practices. * Helping to shape future product features and functionality. Qualifications: * Bachelor of Science, Master of Science, or Ph.D. degree (or equivalent) in a specialty area such as PKPD/Pharmacometrics; Pharmacology, Toxicology, Statistics, Computational/Systems Biology; System Control or Bioengineering, Mathematics or a related discipline. * 3-5 years of industry/consulting experience (may be combined with academic research). * Well-developed work plan writing skills. Excellent writing, editing, verbal communication, and interpersonal skills. * Ability to simultaneously manage multiple projects. * Independent performance of analysis and modeling with little to no supervision and development of reports with minimal modifications required upon review. * Demonstrable communication skills, as evident by presentation at scientific meetings, and good interpersonal and organizational skills. * Proficiency in PK/PD software with at least one of the following software packages: WinNonlin, Phoenix NLME, Adapt, NONMEM, WinBUGS, MONOLIX or any other commonly used PKPD tool; mathematical analysis/simulation platforms such as Matlab, acslX; statistical software such as S-PLUS/R/SAS. * Good working knowledge of modeling (e.g., PK and PK/PD analyses, dose-response and exposure-response analyses, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling). * Knowledge of PK/PD properties of small and large molecules, pediatric drug development. * Knowledge of software development process and principles of software design. * Knowledge of parallel programming techniques such as MPI and OpenMP. Applications Email resume to: [email protected] OR Send to: Attn: Human Resources Certara 5520 Dillard Dr., Suite 260 Cary, NC 27518