PKPD Programmer
3 tygodni temu
About Certara
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.
We are the largest Clinical Pharmacology & Pharmacometric organization in the world, which enables us to assure that various career pathways are offered which match the ambition and personal interests of our employees As one of Certara’s divisions, we deliver value by integrating advanced simulation approaches into the most crucial drug development deliverables - to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience in working on thousands of drug development projects on behalf of hundreds of biopharma companies, we bring a track record of success and a broad range of expertise to each assignment.
*Open to candidates seeking remote opportunities*
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
BSc, MSc or equivalent in Pharmaceutical- or Life Sciences, Statistics/Mathematics/Bio-Informatics, or related fields with 1- 5 years’ experience in data management and analysis, report writing, and regulatory drug submissions. Advanced user of SAS software (SAS9-Base) with proven experience in life sciences and clinical trials. Familiar in working with CDISC data formats. Experience with the R software platform is a plus. General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology. Accuracy and sense of urgency and quality, timely delivery. Ability to work on multiple collaborative projects, team player mentality. Excellent verbal and written communications skills in English. Eager to learn and develop.
