Modeling & Simulations Scientist II PKPD Programming

Job Description

General Summary:

The Modeling & Simulations Scientist II-(PKPD Programming) is a primarily hands-on programming leader responsible for delivering high-quality PK/PD PopPK and exposure-response analysis datasets outputs and regulatory submission deliverables while advancing process standardization automation and quality across Phase 13 studies. This role also provides team and operational management through resource planning mentoring workload coordination and oversight of programming activities to ensure timely compliant and efficient delivery. By combining technical expertise with people leadership the position supports Clinical and Quantitative Pharmacology objectives and contributes to the successful execution of the development portfolio.

Key Duties and Responsibilities:

• Lead hands-on PK/PD programming deliverables by creating validating and delivering analysis-ready datasets outputs and supporting files for Population PK PK/PD and exposure-response analyses ensuring high-quality and timely support for clinical pharmacology objectives.
• Drive programming quality consistency and process standardization across studies by establishing refining and implementing repeatable workflows specifications QC practices and programming standards to improve efficiency reduce risk and support inspection readiness.
• Provide technical oversight and quality control of analysis datasets and data manipulation by reviewing programming methods validating derived datasets and ensuring outputs used by analysts are accurate traceable and fit for purpose.
• Develop and maintain automated programming solutions for Phase 13 studies to streamline dataset generation reporting and submission preparation thereby optimizing timelines and increasing operational scalability.
• Support regulatory and clinical study reporting deliverables by managing submission-ready packages including datasets scripts model files and related documentation and contributing to TFL outputs and clinical pharmacology sections of CSRs or other study documents as needed.
• Provide day-to-day leadership mentoring and technical guidance to PK/PD programmers by coaching team members supporting skill development and promoting sound programming practices and decision-making to strengthen overall team capability.
• Manage programming resources priorities and workload planning in collaboration with Clinical and Quantitative Pharmacology stakeholders to ensure appropriate support across the portfolio alignment to timelines and proactive identification of resource gaps or competing demands.
• Monitor delivery performance and resolve operational issues by tracking progress reporting status and metrics addressing escalations and identifying root causes and corrective actions to maintain reliable and effective programming support.
• Ensure team readiness compliance and operational support by confirming programmers have appropriate system access training tools and procedural guidance needed to perform work in accordance with quality standards regulatory expectations and company processes.

Knowledge and Skills:

• Strong knowledge of PK/PD Population PK and exposure-response programming including development and QC of analysis-ready datasets and outputs to support clinical pharmacology analyses.
• Advanced proficiency in R programming and strong understanding of clinical trial data structures derivations and traceability.
• Solid understanding of quality control validation practices and regulatory submission requirements for datasets scripts model files and related documentation.
• Demonstrated ability to standardize processes and implement automation to improve quality consistency and efficiency across studies.
• Effective project priority and stakeholder management skills with the ability to coordinate multiple deliverables and resolve operational issues in a fast-paced environment.
• Proven people leadership mentoring and communication skills to guide programmers support development and ensure high-quality delivery aligned with business needs.

Education and Experience:

• B.s M.s or PhD with preference in Pharmaceutical sciences Pharmacometrics mathematics computer science statistics or other quantitative discipline.
• Typically requires the following: PhD and 0 years experience or Masters Degree and 4 years experience or Bachelors degree and 6 years of experience in the application of programming or modeling methodologies in the context of drug research & development in industry academia or regulatory agencies

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Remote-Eligible role you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion youre always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Remote

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at