Senior Statistical Programmer (Pharmaceutical Development)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Location: Hybrid; North Wales, Pennsylvania, or Rahway, New Jersey, United States. Domestic relocation is available, and the role requires 10% travel. The posting is for residents of the United States, Canada, and Puerto Rico.
Salary: $117,000–$184,200 annual base salary for the primary location; annual bonus and long-term incentive may also apply.
Company
develops pharmaceutical products across therapeutic areas and conducts research and development supported by statistics, clinical data, and pharmacokinetic modeling.
What you will do
- Develop, validate, and maintain complex clinical-trial datasets, tables, listings, and figures.
- Retrieve and transform source data into analysis and modeling datasets according to statistical and modeling analysis plans.
- Provide technical consultation and analytical support for statisticians and pharmacokinetic modelers, including exploratory and unplanned analyses.
- Prepare compliant programming code and documentation for regulatory submissions.
- Ensure traceability from source data to analysis and modeling results.
- Support programming standards and collaborate with statisticians, PK modelers, stakeholders, and global outsource programming partners.
Requirements
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or a related field plus 5–9 years of SAS/R programming experience in a clinical-trial environment; or MS in one of these fields plus 3–7 years of such experience.
- Experience with CDISC SDTM and ADaM standards.
- Significant SAS or R programming experience for data manipulation, analysis, and reporting.
- Experience developing research and development analysis and reporting deliverables, including data, analyses, tables, graphics, and listings.
- Ability to design and develop complex programming algorithms and implement statistical methods not available in commercial software packages.
- Ability to understand statistical terminology, concepts, and analysis plans.
- Experience handling non-standard data in varied formats with minimal requirements and knowledge of pharmaceutical development processes.
- Effective interpersonal, negotiation, collaboration, written, oral, and presentation skills.
- Ability to lead projects, complete tasks independently at project level, and collaborate with key stakeholders.
Nice to have
- Programming expertise with pharmacokinetic data, including raw concentration data and derived PK parameters.
- Familiarity with clinical pharmacology and pharmacokinetics concepts.
- Experience manipulating very large databases and working with clinical endpoint data, including efficacy and safety data.
- Experience with software other than SAS, such as R, Python, or NonMem.
- Knowledge of reporting processes, SOPs, and the software development life cycle.
- Experience contributing to standard departmental SAS macros.
- Ability and interest to work across cultures and geographies.
- Ability to complete statistical programming deliverables through global outsource partner programming staff.
- Active participation in professional societies.
Culture & Benefits
- Hybrid work arrangement with a regular employee status.
- Medical, dental, vision, and other insurance benefits for employees and families.
- Retirement benefits, including a 401(k).
- Paid holidays, vacation, compassionate leave, and sick days.
- Inclusive environment that values diverse perspectives and collaborative problem-solving.
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