Job Description
_Associate Principal Scientist, Statistical Programming – Rahway, NJ:_
- Provide high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders Oncology therapeutic area.
- Gather and interpret user requirements, retrieve the required data, transform the data into modeling-ready analysis datasets, and develop tables and figures according to the modeling analysis plans.
- Lead the data stewardship and take accountability for the creation of modeling data from original data source(s) to final modeling dataset.
- Act as a key collaborator with modelers, statisticians and other project stakeholders and execute project plans efficiently and oversee the work of other team members when opportunities arise.
- Programmatically synthesize preclinical / clinical data into analysis ready structures from varied data sources.
- Create modeling-ready datasets by integrating PK, PD and covariate data.
- Produce tables and graphics for inclusion in study reports and regulatory submissions.
- Ensure programmatic traceability from data source to modeling result.
- Support the development of programming standards to enable efficient and high quality production of programming deliverables.
- Produce SAS transport files and associated documentation for regulatory submissions.
- Represent statistical programming on process improvement activities.
Education Requirements:
- Must have a Bachelor’s degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Pharmaceutical Sciences, or related field plus 9 years SAS programming experience in a clinical trial environment
- OR
- Master’s degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Pharmaceutical Sciences, or related field plus 7 years SAS programming experience in a clinical trial environment.
Position Requirements:
- Must possess significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; and programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).
- Ability to design and develop complex programming algorithms; to efficiently manipulate clinical trial datasets including complex data preprocessing, filtering, and manipulation; demonstrated ability to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements.
- Knowledge of pharmaceutical development processes.
- Ability to comprehend analysis plans which may describe methodology to be programmed.
- Understanding of statistical or pharmacokinetic terminology and concepts; and ability to implement statistical methods not currently available through commercial software packages also required.
- Must possess broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
- Ability to lead at a program level; ability to determine approach and ensure consistency and direct development of others when opportunities arise; ability to engage key stakeholders required.
- Must possess strong project management skills; excellent interpersonal skills; ability to negotiate and collaborate effectively; and excellent written, oral, and presentation skills.
