Bioinformatics, Biostatistics, Data Analysis, Data management, Drug Discovery, Effective communication skills, R Programming, Statistics, Writing
About our Integrated Drug Development Biostatistics Department
Certara Integrated Drug Development – Quantitative Science Services (IDD – QSS) is the largest pharmacometric consulting organization in the world. Biostatistics, which is made up of statisticians and statistical programmers, is a relatively new service group at Certara, which provides the successful candidate the opportunity to help build a team from the ground up. This enables us to assure that various career pathways are offered to match the ambition and personal interests of our employees! As one of Certara’s teams, we deliver value by providing high-quality datasets, accurate analyses, and first-rate reporting to strengthen global regulatory submissions. Our current employees have deep experience in drug development in multiple therapeutic areas and bring a track record of success and a broad range of expertise to our growing department.
Responsibilities
As data programmer you manage and prepare CDISC ADaM/SDTM data sets (ADPC, PP and ADPP) and data for state-of-the-art analysis, such as PopPK or drug exposure-response (PKPD). You interact directly with the client on topics around data transfers, dataset specifications and data queries. Following completion of the project deliverables, you will create an electronic submission package for future submission to regulatory agencies. In addition, you will conduct quality control and quality assurance activities on datasets and reports and may participate in company initiatives to improve efficiency of data management, analysis and reporting (IT, methodology, automation, quality).
As data programmer you will work closely in teams with other associates, (experts) modelers and drug development consultants supporting a wide variety of client projects (therapeutic areas, data types).
Qualifications
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.