Associate Principal Scientist, Statistical Programming

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. Responsibilities Gather and interpret user requirements, retrieve required data, transform it into modeling‑ready analysis datasets, and develop tables and figures according to modeling analysis plans. Lead data stewardship, taking 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, execute project plans efficiently and oversee the work of other team members when opportunities arise. Programmatically synthesize preclinical and 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 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 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 the same fields plus 7 years SAS programming experience in a clinical trial environment. Position Requirements: 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; 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. Ability to comprehend analysis plans describing methodology to be programmed. Understanding of statistical or pharmacokinetic terminology and concepts; ability to implement statistical methods not currently available through commercial software packages. 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; determine approach and ensure consistency and direct development of others when opportunities arise; engage key stakeholders. Strong project management skills; excellent interpersonal skills; ability to negotiate and collaborate effectively; excellent written, oral, and presentation skills. Salary The salary range for this role is $144,373.00 - $224,100.00 per year; the successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Benefits We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. Equal Employment Opportunity 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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement. #J-18808-Ljbffr MSD Malaysia