Associate Principal Scientist, Statistical Programming
Job Description Associate Principal Scientist, Statistical Programming – Rahway, NJ Responsibilities Provide high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders in the 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. Qualifications & 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 a Master’s degree (or US equivalent) plus 7 years SAS programming experience. Significant expertise in SAS and clinical trial programming, including data steps, procedures, SAS/MACRO, SAS/GRAPH, and programming of clinical endpoint data and pharmacokinetic data. Ability to design and develop complex programming algorithms and efficiently manipulate clinical trial datasets, including complex 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 and statistical or pharmacokinetic terminology and concepts. Experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings). Strong project management, interpersonal, negotiation, collaboration, written, oral, and presentation skills. Salary & Benefits Salary range: $144,373.00 – $224,100.00 per year. Eligible for annual bonus and long‑term incentive if applicable. Benefits include medical, dental, vision, healthcare, retirement (401(k)), paid holidays, vacation, compassionate and sick days. Equal Employment Opportunity & EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. J-18808-Ljbffr