Hybrid Associate Principal Statistical Programmer – Early Stage Development, Pharmacokinetic/Pharmacodynamic Modeling and Simulation

at MSD

• Job title: Associate Principal Statistical Programmer – Early Stage Development, Pharmacokinetic/Pharmacodynamic Modeling and Simulation
• Job type: Full Time
• Experience level: Junior, Mid level
• Salary: $139,600 - $219,700 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, North Wales, United States

About the role

• Statistical Programmer providing high quality programming analysis and reporting deliverables. Collaborating with global stakeholders in Early Development Statistics and PK/PD modeling.

Responsibilities

• Provide high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics and global PK/PD modeling and simulation stakeholders spanning all our company therapeutic areas except early oncology
• Gather and interpret user requirements for analysis and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues
• Retrieve the required data, transform the data into analysis/modeling datasets, and develop tables and figures according to statistical/modeling analysis plan
• Partner with stakeholders to solve problems; reduce the amount of programming task being completed by stakeholders to facilitate an increase in efficiency and compliance for statistical/modeling analyses
• Write programs to analyze data with statistical methods which are not currently available through commercial software packages
• Be a key collaborator with statisticians, modelers, and colleagues in other related function areas
• Pre-process, filter, and manipulate complex data for the analyses of molecular biomarker data, imaging data, and external data other than traditional laboratory data
• Provide technical consultation and analytical support to early development statisticians for exploratory and unplanned statistical analyses
• Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and associated documentation
• Ensure programmatic traceability from data source to analysis/modeling result
• Maintain and manage a project plan including resource forecasting
• Support the development of programming standards to enable efficient and high-quality production of programming deliverables
• Represent statistical programming on process improvement activities

Requirements

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment
• Excellent interpersonal skills and ability to negotiate and collaborate effectively
• Excellent written, oral, and presentation skills
• Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
• Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders
• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH
• Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages.
• Experience in CDISC SDTM and ADaM standards
• Demonstrated success in the assurance of deliverable quality and process compliance
• Thrives in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes
• Efficiently manipulates very large databases including complex data preprocessing, filtering, and manipulation
• Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters)
• Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days