Senior PK Analyst

Posted 6 Hours Ago
Be an Early Applicant
3 Locations
Remote
Senior level
Pharmaceutical
The Role
Provides expert pharmacokinetic and pharmacodynamic analysis support for clinical development projects. Responsibilities include deriving PK/PD parameters, programming and validating NONMEM and PK/PD datasets, producing statistical tables and figures, ensuring regulatory and quality compliance, improving processes, and mentoring analysts. The role works independently with sponsors and internal stakeholders across complex projects.
Summary Generated by Built In

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel is looking for a Senior PK Analyst to be remotely based but living in any of the following locations:
 

South Africa
Poland
Italy
Romania

 

The Senior PK Analyst is recognized as a subject matter expert, providing technical support and expert advice to internal and external stakeholders including sponsors and within the Clinical Pharmacology, Modelling & Simulation (CPMS) team. They are responsible for the derivation of Pharmacokinetic (PK), and Pharmacodynamic (PD) parameters including the programming and validation of NONMEM datasets, PK/PD derived datasets and tables, listings, figures, and statistical appendices. This person will be required to work independently on clinical development projects of all levels of complexity. The Senior PK Analyst also provides support to other analysts including programming assistance, query resolution, mentoring and training.

Key Accountabilities:

  • Derivation of Pharmacokinetic (PK), and Pharmacodynamic (PD) parameters.

  • Programming and validation of NONMEM datasets and PK/PD derived datasets.

  • Programming and validation of tables, listings, figures, and statistical appendices if applicable.

  • Execute activities according to the agreed processes (SOP’s) and timelines while maintaining good quality.

  • Ensures that the deliveries match the agreed specifications and expectations.

  • Apply good programming practices; works according to International Conference on Harmonization and Good Clinical Practice standards.

  • Proactively participate in and/or lead process/quality improvement initiatives.

  • May serve as process/system owner responsible for development, implementation and maintenance of process/systems in collaboration with key stakeholder functions (e.g. IT Technology, Quality)

Knowledge and Experience:

  • 4-6 years relevant experience

  • Expert knowledge of SAS (SAS/BASE, SAS/STAT, and SAS/GRAPH) or R or both. However, R is preferred.

  • Experience with Phoenix WinNonlin or equivalent

  • Knowledge of pharmacokinetic data

  • Advanced skills in Microsoft applications

  • Understand regulatory requirements concerning industry technical standards

  • Unix and/or Linux knowledge is advantageous.
     

Skills:

  • Ability to learn new systems and function in an evolving technical environment.

  • Professional attitude, self-motivated, logical thinking.

  • Excellent attention to detail.

  • Excellent interpersonal, verbal, and written communication skills.

  • Strong project management skills

  • Client focused approach to work ethic.

  • Ability to manage multiple and varied tasks with enthusiasm and independently prioritize workload, demonstrated flexibility to change.

  • Good standard of written and spoken English

  • Ability to negotiate and influence to achiever results.

  • Ability to resolve complex issues in creative and effective ways.

  • Ability to work well under pressure and to keep to scheduled timelines.

  • Ability to work with line- and middle-management on a functional level.

Education:

  • A bachelor’s degree or equivalent in a programming, statistics or mathematics discipline is preferable.  Post graduate qualification is advantageous

Skills Required

  • 4–6 years of relevant experience
  • Expert knowledge of SAS/BASE, SAS/STAT, and SAS/GRAPH, or R; R preferred
  • Experience with Phoenix WinNonlin or equivalent
  • Knowledge of pharmacokinetic data
  • Advanced Microsoft application skills
  • Understanding of regulatory requirements and industry technical standards
  • Bachelor’s degree or equivalent in programming, statistics, or mathematics
  • Unix and/or Linux knowledge
  • Postgraduate qualification
  • Strong project management, communication, analytical, and organizational skills
  • Good written and spoken English

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

Parexel Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Raleigh, NC
20,524 Employees

What We Do

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Similar Jobs

Pfizer Logo Pfizer

Director R&D EHS Program Lead

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
In-Office or Remote
36 Locations
121990 Employees
177K-294K Annually

Mondelēz International Logo Mondelēz International

o9 Change Readiness Lead

Big Data • Food • Hardware • Machine Learning • Retail • Automation • Manufacturing
Remote or Hybrid
11 Locations
90000 Employees

Capco Logo Capco

Artificial Intelligence Engineer

Fintech • Professional Services • Consulting • Energy • Financial Services • Cybersecurity • Generative AI
Remote or Hybrid
Italy
6000 Employees
65K-65K Annually

CrowdStrike Logo CrowdStrike

Regional Sales Manager

Cloud • Computer Vision • Information Technology • Sales • Security • Cybersecurity
Remote or Hybrid
Italy
11000 Employees

Similar Companies Hiring

Formation Bio Thumbnail
Artificial Intelligence • Big Data • Healthtech • Biotech • Pharmaceutical
New York, NY
150 Employees
Pfizer Thumbnail
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
New York, NY
121990 Employees
Cencora Thumbnail
Healthtech • Logistics • Pharmaceutical
Conshohocken, PA
51000 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account