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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. We are the largest Clinical Pharmacology & Pharmacometric organization in the world, integrating advanced simulation approaches into the most crucial drug development deliverables to inform internal decision‑making and strengthen global regulatory submissions.
Responsibilities
As a data programmer you manage and prepare CDISC ADaM/SDTM data sets (ADPC, PP, ADPP) and data for state‑of‑the‑art analysis, such as PopPK or drug exposure‑response (PKPD). You interact directly with clients on data transfers, dataset specifications, and data queries. Following project deliverables, you create electronic submission packages for regulatory agencies, conduct quality control and assurance activities on datasets and reports, and may participate in initiatives to improve efficiency of data management, analysis, and reporting (IT, methodology, automation, quality). You work closely with other associates, modelers, and drug development consultants across therapeutic areas and 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 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, sense of urgency, and quality with timely delivery.
* Ability to work on multiple collaborative projects and a team‑player mentality.
* Excellent verbal and written communication skills in English.
* Eager to learn and develop.
Certara bases all employment‑related decisions 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 characteristics protected by law.
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