Conducts PK/PD analyses, interprets and reports results, and contributes to all phases of a clinical study involving PK/PD characterization On the project level, assists in study start-up activities and evaluates data related to the PK/PD characterization of a drug
Participates as a key team member on PK/PD projects
Provides specific input into PK/PD study CRF design to ensure complete collection of data required for proper PK/PD analysis
Assists or writes PK/PD sections of Statistical Analysis Plans
Performs PK/PD data analysis and assists in interpreting the statistical results
Assists in writing PK/PD sections of Clinical Study Reports
Designs PK/PD studies; assists in writing clinical study protocols
Works with investigators and their staff and participates in investigator meetings to ensure proper PK/PD collection techniques, sample handling, storage, and shipping
On the program level, provides scientific expertise and oversight to drug development and/or clinical trial project teams through all program stages
Provides expertise regarding bioanalytical data interpretation for the client and internally
Provide expertise in PK modeling, simulations and Population modeling
Writes or assists with writing of PK/PD sections of regulatory submission documents or manuscripts
Performs scientific literature searches and other research to support strategic overview planning and writing of proposals in support of individual clinical trials or for full development programs
Collaborates with clients on the design of drug development programs
Works directly with the project team to provide expertise on the importance of critical PK/PD data in the analytical process and their intended use in a report or submission
Assists with the writing of clinical development plans and business plans
Participates in the RFP process
Provides feedback regarding PK/PD bids; may participate in RFP bid defense
Read, write and speak English; fluent in host country language required.
Proficiency with Phoenix WinNonlin required; Phoenix NLME preferred
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities
Internal Number: 2019-60117
About PRA Health Sciences
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