PKPD Data Manager/SAS Programmer - Associate Scientist

Certara Strategic Consulting is looking for PKPD Data Managers / SAS Programmers local to our Raleigh, NC or Parsippany, NJ offices!

Certara

Certara is a growing company that provides a novel 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 Strategic Consulting (CSC)

Certara Strategic Consulting (CSC) is a division of Certara and is the largest and most comprehensive model-informed drug development and strategic pharmacometrics organization. CSC delivers value by integrating advanced modeling and simulation approaches into the most crucial drug development deliverables—to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience working on thousands of key drug development projects on behalf of hundreds of biopharma companies, CSC brings its track record of success and a broad range of expertise to each assignment.

For more information on Certara Strategic Consulting, please visit https://www.certara.com/wp-content/uploads/Resources/Brochures/BR_CertaraConsultingServices.pdf

PKPD Data Manager/SAS Programmer (Associate Scientist)

The PKPD Data-Manager will serve on client consulting teams to perform data management and exchange activities for the project. The PKPD Data-Manager will be responsible for conducting data-management and programming in support of the conduct, reporting, and submission of PK and PD analyses, including both non-compartmental and population analyses.

In addition, the PKPD Data Manager will participate in coordination of company activities (e.g. IT, methodology, automation) to improve efficiency and quality of dataset construction, analysis workflow, reporting, and submission of data to health authorities.

The qualified candidate will have a BS, or equivalent in Data Sciences, Pharmaceutical Sciences, Pharmacology, Toxicology, Statistics, Mathematics, or related fields with a minimum 1 to 5 years’ experience and expertise in PKPD data analysis, data management, reporting, and regulatory submission requirements. Special emphasis is placed on familiarity with regulatory requirements and trends with respect to data standards.

Skills & Abilities

Basic understanding of data collection and database concepts including data flows in clinical trials, and Pharma industry data standards, such as CDISC/SDTM and ADaM data models.
Must be an expert in SAS dataset construction, with a strong preference for familiarity with PK and PKPD datasets (e.g., WinNonlin, NONMEM), R skills are a plus.
Demonstrated ability to produce the major deliverables associated with the planning, execution, and reporting of a clinical study.
Demonstrated ability to produce Pharma industry data standard and Sponsor defined clinical data deliverables
General knowledge of clinical drug development and demonstrated knowledge of pharmacokinetics and pharmacology is preferred.
Proficiency in performing PK and statistical analysis using software (e.g., WinNonlin, Phoenix, AutoPilot and SAS, R) is preferred.
Entry level developing PK(PD) modeling is a plus.
Accuracy and a sense of urgency are key in delivering high quality on time.
Ability to support and coordinate multiple projects as requested.
Strong collaborative skills, team player mentality.
Excellent verbal and written communications skills in English.

Working at Certara Strategic Consulting

ThePKPD Data-manager / SAS Programmer will work closely in teams with other Associates, modelers and drug development consultants supporting projects for Certara’s clients. The PKPD Data-Manager Lead will have the ability to work on a variety of therapeutic indications and data types. Personal development is not only provided, it is expected.

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