The company is looking to solve the problem of integrating data from diverse sources for pharmacometric analyses to support regulatory filings, internal decisions, and HA interactions.
Requirements
- Excellent proficiency in SAS or R programming language.
- Skilled in Python programming.
- Certification in SAS, R or Python.
- Competence in UNIX or Linux, and skill with bash scripting and UNIX filters.
- Knowledge of pharmacokinetic data, clinical data, NONMEM concepts and data issues with programming NONMEM data sets.
- Ability to implement sophisticated algorithms to derive complex data sets and address data issues.
- Familiarity with principles of quality control.
Responsibilities
- Utilize expert knowledge of SAS or R to integrate clinical data and pharmacokinetic data to prepare analysis datasets for pharmacometric analysis in NONMEM and other modeling tools.
- Implement sophisticated algorithms to derive complex data sets, and address data issues with supervision.
- Prepare submission packages including datasets, tables, listings, and figures, authoring data section of the PMx report, for filing with health authorities and responses to queries from health authorities.
- Use visualization software for validation and quality check.
- Work on outsourced projects.
- May contribute to continuous improvement initiatives for process efficiencies, including developing Artificial Intelligence/Machine Learning (AI/ML) solutions.
- Stay up to date on all role-based training.
Other
- Responsible and accountable for high quality PMx analysis datasets and reports across all therapeutic areas.
- Apply solid knowledge of pharmacokinetics, pharmacodynamics, and other scientific areas to partner with experts to integrate data sources efficiently and effectively.
- Strong attention to quality and detail, with the ability to detect data anomalies.
- Excellent interpersonal and communication skills.
- Bachelor's degree in engineering, science, computer science, mathematics, or statistics.
- Master's or higher degree preferred.
- Local and international travel for conferences may be required 5-10% of the time.
