Dear NONMEM users:
Duke Medical Center is looking for a pharmacokineticist. Below is the job
description. Please go to
Performs pharmacokinetic (PK)/statistical analysis and programming for
phase 1- 3 clinical trials and/or clinical research projects. Collaborates
closely with a cross-functional trial/project team, physicians, and
external government or industry representatives with regard to
PK/statistical aspects of each clinical trial/project. Coordinates the
PK/statistical needs of each clinical trial/project.
With appropriate guidance, prepares PK/statistical analysis plans.
Independently generates descriptive and basic test statistics, analysis of
basic data requests, and statistical modeling results.
Learns new statistical and PK methods as needed, and applies new skills to
Performs non-compartmental, compartmental, and population
PK/pharmacodynamic (PD) analyses.
Works independently during the analysis and, under guidance, refines
Documents analyses, creates summaries, and presents results in written,
verbal, and graphical form to requestors. Able to work on any phase of a
manuscript project, from initial meeting with an investigator to final
review of a manuscript prior to submission for publication, with guidance.
Possesses documentation and organizational skills needed to effectively
return to a trial or manuscript project after long intervals during which
no progress has been made by other members of the project team. Contributes
meaningfully to discussions of analyses and identifies next steps for
Designs analysis data set specifications through writing original SAS,
STATA, and R code; finds errors, corrects, and validates output and
results. Performs complex programming, such as data transposition and
macros. Programs analysis datasets using SAS, STATA, or R;combines multiple
disparate raw databases and derives analysis variables accurately,
including data needed for PK and PD analyses. Uses complicated SAS, STATA,
or R procedures and options and programs with increasing efficiency.
Collaborates effectively with statistical programmers to support their
Identifies potential data problems from analytic queries and brings them to
the attention of the team. Demonstrates understanding of clinical
trial/project data collection processes and data sets
and shares knowledge with collaborators.
Participates in most statistical and PK aspects of a clinical
trial/project, with consultation or assistance when needed. Represents the
functional group in project team meetings and contributes constructively to
project discussions. Understands thecontracted scope of work and forecasts
monthly hours expected to complete each trial/project.
Creates timelines for PK/statistical project management, with assistance
from the project leader and PK/statistical managers.
Understands study data and the intricacies of the process through which it
is being collected.
Handles and secures highly confidential and sensitive analyses and
Supports the preparation of data and safety monitoring board reports and
final statistical, PK, and study reports, including those intended for
regulatory submission, and collaborates with medical writers as needed.
Collaborates closely with investigators, sponsors, and other trial leaders
to ensure that trial/project results and conclusions are presented
accurately and without bias.
Leads or participates actively in the PK/statistical team responsible for
designing and validating analysis data sets, programs, and statistical
output products (tables, listings, figures).
Adheres to standard operating procedures of the functional department as
they apply to documentation and validation of clinical research
PK/statistics. Understands guidelines from the FDA, ICH, EMEA, NIH, or
other regulatory agencies as they apply to PK/statistics and programming
expectations for each project.
Collaborates effectively with a variety of individuals: programmers,
pharmacokineticists, statisticians (both junior and senior), medical
personnel, and representatives within the business community.
Possesses leadership and communication skills.
Manages project responsibilities with decreasing levels of supervision or
regular support, and takes initiative to complete project-specific
responsibilities with minimal supervision.
Demonstrates progress in ability to multi-task.
Performs other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being
performed by individuals assigned to this classification. This is not
intended to be an exhaustive list of all responsibilities and duties
required of personnel so classified.
Required Qualifications at this Level
Education/ Training: Work requires a minimum of a master's degree in
biostatistics OR PharmD with knowledge of PK/PD analyses in NONMEM, or a
bachelor's degree in (bio)statistics or related field and 2 years'
relevant experience in clinical PK, or an equivalent combination or
relevant education and/or work experience.
Experience: Knowledge of PK and pharmacology concepts and PK/PD analyses
Knowledge of the use of clinical PK for designing early-phase human studies
Solid command of the English language is required
Knowledge on clinical database, PK/PD data compilation, and manipulation
with scripting software of NONMEM and SAS, STATA, or R Knowledge of
PK/PD/statistical software including WinNonLin; SAS, STATA
or R; and NONMEM to function independently under guidance
Knowledge of clinical trial simulations a plus
Knowledge of pediatric drug development a plus
Good knowledge of Microsoft Word, Excel, and PowerPoint
Good written and oral presentation skills
Ability to organize and work simultaneously on multiple projects
80% PK/PD/statistical analyses
5% software training of trainees
Work requires a minimum of a PharmD, MD, or PhD with knowledge of PK/PD
analyses, or a Master's degree in biostatistics with at least 2 years of
experience in clinical PK.
Huali Wu, Ph.D.
Duke Clinical Research Institute
Received on Mon Nov 24 2014 - 09:18:12 EST