Sr. R Programmer (PK/PD)

ProPharma•Raleigh, NC

About The Position

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Uses R and companion software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Summary of the Essential Functions of the Job Data preparation and cleaning: Cleaning and transforming raw clinical trial data from various sources to ensure accuracy and consistency for PK/PD analysis. Programming PK/PD analyses: Writing R or Rmarkdown code to perform descriptive analysis of PK/PD data and statistical analysis of exposure-response relationships. Data visualization: Creating clear and informative graphs and tables to effectively communicate PK/PD findings. CDISC compliance: Ensuring data is formatted according to CDISC standards for regulatory submissions Validation and quality control: Performing thorough validation checks on programming code and analysis results to maintain data integrity. Identifies problems and develops tools that increase the efficiency and capacity of the Clinical PK/PD Programming group.

Requirements

Bachelor’s degree in Math, Stats, Computer Science or similar
3+ years of industrial experience
Must have advanced R programming skills, including tidyverse, ggplot2, Markdown, Quarto, Shiny, etc.
Knowledge of CDISC standards (SEND, SDTM, and ADaM) is required.
Desire to work in clinical PK/PD – knowledge and experience of PK/PD concepts and related programming is highly desirable.
Experience visualizing/presenting data for internal stakeholders or clients
Capable of implementing more advanced modeling and statistical procedures as requested by study team.
Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis, and reporting/modeling of analysis results. Including handling of data issues and uncleaned data.
Professional attitude, self-motivated, logical thinking
Excellent attention to detail
Strong organization skills and ability to work on multiple tasks simultaneously while achieving quality standards and meeting deadlines
Good verbal and written communication skills.
Strong interpersonal skills and ability to work collaboratively across teams
Ability to problem solve and develop innovative approaches along with a drive to learn and master new techniques and technologies

Nice To Haves

Python and/or SAS programming skills are a plus, but not required.

Responsibilities

Data preparation and cleaning: Cleaning and transforming raw clinical trial data from various sources to ensure accuracy and consistency for PK/PD analysis.
Programming PK/PD analyses: Writing R or Rmarkdown code to perform descriptive analysis of PK/PD data and statistical analysis of exposure-response relationships.
Data visualization: Creating clear and informative graphs and tables to effectively communicate PK/PD findings.
CDISC compliance: Ensuring data is formatted according to CDISC standards for regulatory submissions
Validation and quality control: Performing thorough validation checks on programming code and analysis results to maintain data integrity.
Identifies problems and develops tools that increase the efficiency and capacity of the Clinical PK/PD Programming group.

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