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in Princeton, NJ

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Hours Full-time, Part-time
Location Princeton, New Jersey

About this job

Overview

About Certara

Certara is a growing company that provides a dynamic and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.

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.

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

  • 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.