PKPD programmer - Wyatt, IN, United States - Aurora Solutions

Aurora Solutions
Aurora Solutions
Verified Company
Wyatt, IN, United States

2 days ago

James Miller

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James Miller

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Freelance
Description

Overview:


Certara is a leading company in the field of biosimulation software, technology, and services, dedicated to accelerating the development of medicines.

With clients in over 62 countries, including biopharmaceutical companies, academic institutions, and regulatory agencies, we are the largest Clinical Pharmacology & Pharmacometric organization in the world.

We offer a variety of career opportunities that align with the ambitions and interests of our employees.

As part of Certara, our division integrates advanced simulation techniques into critical drug development processes to inform decision-making and strengthen global regulatory submissions.

With a proven track record of success and a wide range of expertise, we are committed to delivering value to our clients.


Responsibilities:


As a data programmer in our team, you will be responsible for managing and preparing CDISC ADaM/SDTM data sets (ADPC, PP, and ADPP) and data for advanced analysis, such as PopPK or drug exposure-response (PKPD).

You will directly interact with clients on topics related to data transfers, dataset specifications, and data queries. Once the project deliverables are completed, you will create an electronic submission package for future regulatory submissions.

Additionally, you will conduct quality control and assurance activities on datasets and reports, and may also participate in company initiatives to improve the efficiency of data management, analysis, and reporting (IT, methodology, automation, quality).

As a data programmer, you will work closely with other team members, including associates, experts, model
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