Merck · 8 hours ago
Assoc Principal Statistical Programmer, Early Stage Development and Pharmacokinetic/Pharmacodynamic Modeling and Simulation (Hybrid)
North Wales, PA
Full-time
Hybrid
Senior Level, Lead/Staff
$140K/yr - $220K/yr
7+ years expMerck is a renowned company in the pharmaceutical industry, seeking an Associate Principal Statistical Programmer to provide high quality statistical programming analysis and reporting deliverables. The role involves collaborating with stakeholders to gather user requirements, developing programming code for analyses, and ensuring compliance with regulatory submissions.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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
Qualification
Required
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
Designs and develops complex programming algorithms
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
Preferred
Familiarity with clinical pharmacology concepts and pharmacokinetics concepts
Experience with at least one other software than SAS (e.g., R, Splus, NonMem)
Good working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
Utilizes and contributes to the development of standard departmental SAS macros
Ability and interest to work across cultures and geographies
Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
Experience providing technical and/or programming guidance and mentoring to colleagues
Experience in process improvement
Active in professional societies
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
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital Advisors"Gavi, the Vaccine Alliance"
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-02-05
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2026-02-05
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