Associate Principal Scientist, Statistical Programming

Merck Merck · Pharma · NJ

This role focuses on statistical programming within the pharmaceutical industry, specifically for Oncology therapeutic area. The responsibilities include data analysis, reporting, data stewardship, and creating modeling-ready datasets and deliverables for regulatory submissions using SAS. It requires significant expertise in SAS programming and clinical trial data.

What you'd actually do

  1. Provide high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders Oncology therapeutic area.
  2. 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.
  3. Lead the data stewardship and take accountability for the creation of modeling data from original data source(s) to final modeling dataset.
  4. 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.
  5. Programmatically synthesize preclinical / clinical data into analysis ready structures from varied data sources.

Skills

Required

  • SAS programming
  • clinical trial programming
  • data steps
  • procedures
  • SAS/MACRO
  • SAS/GRAPH
  • clinical endpoint data programming
  • pharmacokinetic data programming
  • complex programming algorithms
  • clinical trial datasets manipulation
  • data preprocessing
  • filtering
  • manipulation
  • exploratory environment
  • non-standard data handling
  • pharmaceutical development processes
  • analysis plans comprehension
  • statistical terminology
  • pharmacokinetic terminology
  • implement statistical methods
  • analysis and reporting deliverables development
  • project management skills

Nice to have

  • Bachelor’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Pharmaceutical Sciences, or related field
  • Master’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Pharmaceutical Sciences, or related field
  • PK modeling and simulation stakeholders
  • Oncology therapeutic area
  • modeling analysis plans
  • data stewardship
  • preclinical / clinical data synthesis
  • PK, PD and covariate data integration
  • tables and graphics production
  • study reports
  • regulatory submissions
  • programmatic traceability
  • programming standards development
  • SAS transport files
  • documentation for regulatory submissions
  • process improvement activities
  • lead at a program level
  • ensure consistency
  • direct development of others
  • engage key stakeholders
  • excellent interpersonal skills
  • negotiate and collaborate effectively
  • excellent written, oral, and presentation skills

What the JD emphasized

  • 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
  • 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.
  • 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.
  • Must possess broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
  • Must possess strong project management skills