Pk/pd Data Programmer

2 giorni fa

Provincia di Firenze Toscana, Italia Certara A tempo pieno

Overview:
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.
- Certara bases all employment-related decision 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 characteristic protected by law._

**Responsibilities**:
As PK-PD data programmer you manage and prepare data for state-of-the-art analysis, such as PopPK or drug exposure-response (PKPD), typically based on CDISC ADaM / SDTM datasets. You interact directly with the client on topics around data transfers, dataset specifications and data queries. You conduct exploratory analyses in support of these activities. 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 PK-PD 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.
- Proficiency in conducting basic statistical analysis.
- 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.

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