Associate Principal Scientist, Statistical Programming
Merck
3 hours ago
On-site
Rahway, NJ
Clinical Research and Development
Associate Principal Scientist, Statistical Programming – Rahway, NJ
Responsibilities:
- Provide high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders (Oncology).
- Gather and interpret user requirements, retrieve required data, transform into modeling-ready analysis datasets, and develop tables/figures per modeling analysis plans.
- Lead data stewardship and take accountability for creation of modeling data from original sources to final modeling datasets.
- Collaborate with modelers, statisticians, and stakeholders; execute project plans and oversee others when needed.
- Programmatically synthesize preclinical/clinical data into analysis-ready structures from varied data sources.
- Create modeling-ready datasets integrating PK, PD, and covariate data.
- Produce tables/graphics for study reports and regulatory submissions; ensure programmatic traceability from data source to modeling result.
- Support development of programming standards; produce SAS transport files and documentation for regulatory submissions.
- Represent statistical programming on process improvement activities.
Education/Experience:
- Bachelor’s degree in a related field + 9 years SAS programming experience in a clinical trial environment; OR Master’s degree + 7 years.
Position Requirements:
- Significant expertise in SAS clinical trial programming (data steps, procedures, SAS/MACRO, SAS/GRAPH) and programming with clinical endpoint (efficacy/safety) and pharmacokinetic data (raw concentrations, derived PK parameters).
- Ability to design complex programming algorithms; manipulate datasets (preprocessing, filtering, manipulation) in exploratory settings with non-standard formats.
- Knowledge of pharmaceutical development processes and ability to interpret/comprehend analysis plans.
- Understanding of statistical/PK terminology; ability to implement methods not available in commercial software.
- Broad experience developing R&D analysis/reporting deliverables (data, analyses, tables, graphics, listings).
- Program-level leadership, strong project management, interpersonal, negotiation/collaboration, and written/oral/presentation skills.
Responsibilities:
- Provide high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders (Oncology).
- Gather and interpret user requirements, retrieve required data, transform into modeling-ready analysis datasets, and develop tables/figures per modeling analysis plans.
- Lead data stewardship and take accountability for creation of modeling data from original sources to final modeling datasets.
- Collaborate with modelers, statisticians, and stakeholders; execute project plans and oversee others when needed.
- Programmatically synthesize preclinical/clinical data into analysis-ready structures from varied data sources.
- Create modeling-ready datasets integrating PK, PD, and covariate data.
- Produce tables/graphics for study reports and regulatory submissions; ensure programmatic traceability from data source to modeling result.
- Support development of programming standards; produce SAS transport files and documentation for regulatory submissions.
- Represent statistical programming on process improvement activities.
Education/Experience:
- Bachelor’s degree in a related field + 9 years SAS programming experience in a clinical trial environment; OR Master’s degree + 7 years.
Position Requirements:
- Significant expertise in SAS clinical trial programming (data steps, procedures, SAS/MACRO, SAS/GRAPH) and programming with clinical endpoint (efficacy/safety) and pharmacokinetic data (raw concentrations, derived PK parameters).
- Ability to design complex programming algorithms; manipulate datasets (preprocessing, filtering, manipulation) in exploratory settings with non-standard formats.
- Knowledge of pharmaceutical development processes and ability to interpret/comprehend analysis plans.
- Understanding of statistical/PK terminology; ability to implement methods not available in commercial software.
- Broad experience developing R&D analysis/reporting deliverables (data, analyses, tables, graphics, listings).
- Program-level leadership, strong project management, interpersonal, negotiation/collaboration, and written/oral/presentation skills.