Associate Scientist, PKPD Programmer
Overview:
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.
Responsibilities:
Assist in the creation, development and preparation of CDISC ADaM/SDTM data sets (ADPC, PP and ADPP) and data for global organization’s state-of-the-art medicinal and pharmaceutical analysis, such as PopPK or drug exposure-response (Pharmacokinetics/ Pharmacodynamics or PKPD), using company’s bio-simulation software, technology and tools/services in order to transform traditional drug discovery and development.Interact directly with company client’s on topics around data transfers, dataset specifications, and data queries. Create electronic submission packages in proper CDISC data formats for future submission to various regulatory agencies using knowledge of SAS software (SAS9-Base) and experience in life sciences and clinical trials.
Conduct quality control (QC) and quality assurance (QA) activities on datasets and reports and participate in company initiatives to improve efficiency of company’s internal data management, analysis and reporting functions (e.g. IT, methodology, automation, quality). Work closely with cross-functional teams, including other PKPD associate scientists, (experts) modelers and drug development consultants to support a wide variety of covered areas (therapeutic areas, data types, etc.) utilizing clinical drug development knowledge and experience and demonstrated knowledge of pharmacokinetics and pharmacology.
Perform research and design new technical enhancements and approaches in the areas of PKPD data management. Write, maintain and develop high quality programs (R, SAS) and computational algorithms to facilitate the construction of PopPK datasets (e.g., NONMEM, Phoenix NLME, clinical datasets, SAS transport files, define.xml) and work closely with Pharmacometricians to create precise data specifications and offer technical bioinformatics and database support for analyses, such as population PK models, PK/PD analyses, exposure-response analyses, clinical trial simulations, and other quantitative analyses.
Location: This is a telecommute position
Qualifications:
Master’s degree in Biotechnology, Bioinformatics, Applied Statistics and Data Analysis, or Pharmaceutical Science and two (2) years of experience in job offered or two (2) years of clinical data/statistical programming experience in life/health sciences field
Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.