Principal R Programmer
Job
Actalent
Remote
$145,506 Salary, Full-Time
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Job Description
Job Title:
Principal R Programmer - Clinical Pharmacokinetics/Pharmacodynamics (PK/PD) Job Description This role focuses on advanced R programming to support clinical pharmacokinetics/pharmacodynamics (PK/PD) analyses within a pharmaceutical environment. You will prepare, clean, and analyze clinical trial data, build robust PK/PD analysis programs, and produce high‑quality visualizations and outputs for internal stakeholders and regulatory submissions. The position emphasizes hands-on work with complex clinical data, CDISC-compliant datasets, and exposure-response modeling, while also contributing to process improvement and training within the programming group. Responsibilities Prepare, clean, and transform raw clinical trial data from multiple sources to ensure accuracy, consistency, and readiness for PK/PD analysis. Program PK/PD analyses using R and R Markdown (and related tools) to perform descriptive analyses of PK/PD data and statistical analyses of exposure-response relationships. Create clear, informative, and publication-quality graphs, tables, and visual summaries to effectively communicate PK/PD findings to internal stakeholders and study teams. Ensure data and analysis outputs comply with CDISC standards, including SEND, SDTM, and ADaM, to support regulatory submissions. Perform thorough validation and quality control checks on programming code, datasets, and analysis results to maintain data integrity and reproducibility. Identify programming, data, and workflow problems and develop tools, utilities, and processes that increase the efficiency and capacity of the Clinical PK/PD Programming group. Provide training and guidance to fellow programmers on industry guidance, best practices, and new or enhanced software tools relevant to PK/PD programming. Implement advanced modeling and statistical procedures as requested by study teams, particularly in support of exposure-response and other PK/PD analyses. Work extensively with clinical trial data, including uncleaned and complex datasets, to perform data manipulation, analysis, and reporting/modeling of analysis results. Collaborate closely with cross-functional teams, including statisticians, clinical pharmacologists, and clinical operations, to clarify requirements and deliver high-quality analytical outputs. Contribute to regulatory submission work by preparing, reviewing, and validating analysis datasets, code, and outputs used in submission packages. Manage multiple concurrent tasks and projects, prioritizing work effectively to meet quality standards and deadlines. Communicate analysis plans, progress, findings, and issues clearly through verbal and written communication, and participate actively in team discussions and reviews. Apply logical thinking and strong problem-solving skills to resolve data and programming issues and to develop innovative analytical approaches. Demonstrate a professional, self-motivated attitude and contribute positively to a collaborative team culture. Essential Skills Bachelor's degree in Mathematics, Statistics, Computer Science, or a related quantitative field. 7+ years of industrial experience, preferably in the pharmaceutical industry with a focus on clinical data and PK/PD programming. Advanced R programming skills, including strong hands-on experience with tidyverse, ggplot2, R Markdown, Quarto, Shiny, and related R ecosystems. Extensive experience working in a PK/PD environment, with strong exposure to PK/PD concepts and related programming. Strong understanding of clinical trial data structures and processes, with highly hands-on experience in data manipulation, analysis, and reporting/modeling of analysis results. Proven ability to work with uncleaned and complex clinical data, including identification and resolution of data issues. Knowledge and practical experience with CDISC standards, including SEND, SDTM, and ADaM, and their application in regulatory submissions. Experience visualizing and presenting data and analysis results for internal stakeholders or clients using R-based tools. Capability to implement advanced modeling and statistical procedures as requested by study teams, particularly in a PK/PD context. Very strong R programming focus and proficiency, with the ability to design efficient, reliable, and well-documented code. Professional attitude with strong self-motivation and logical, analytical thinking. Excellent attention to detail and commitment to high-quality deliverables. Strong organizational skills with the ability to manage multiple tasks simultaneously while meeting deadlines and quality standards. Good verbal and written communication skills, with the ability to explain technical concepts clearly to non-programmers. Strong interpersonal skills and the ability to work collaboratively across cross-functional teams. Demonstrated ability to solve problems and develop innovative approaches, along with a drive to learn and master new techniques and technologies. Additional Skills & Qualifications Experience working in the pharmaceutical industry (rather than exclusively in a contract research organization). Background working in or closely with US-based pharmaceutical companies and exposure to large-scale clinical trial portfolios. Experience contributing to regulatory submissions, including preparation and validation of CDISC-compliant datasets and outputs. Python programming skills are a plus. SAS programming skills are a plus, though this role is primarily focused on R. Experience with clinical research, clinical programming, and pharmaceutical statistics. Familiarity with PK/PD concepts, analyses, and workflows beyond programming, including interpretation and communication of results. Demonstrated experience training or mentoring other programmers on tools, standards, or best practices. Comfort working in a long-term engagement environment with a large, complex organization. Work Environment This is a remote position that can be performed from any location, with no specific time zone preference. You will work in a highly data-driven, pharmaceutical environment that manages a large number of clinical trials. The role is heavily focused on R programming, supported by an existing team of SAS programmers, and involves extensive use of R, tidyverse, ggplot2, R Markdown, Quarto, and Shiny for analysis and visualization. Collaboration occurs primarily through virtual communication tools, with regular interaction across clinical, statistical, and pharmacometric teams. The work pace is dynamic, with concurrent projects and deadlines, and emphasizes quality, regulatory compliance, and continuous improvement in tools and processes. Job Type & Location This is a Contract position based out of Wilmington, DE. Pay and Benefits The pay range for this position is $67.31 - $72.60/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position.
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