Assoc Prin.Scientist Stat.Programming
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
This position provides high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics and global PKPD modeling and simulation. The Associate Principal Programmer will gather and interpret user requirements for analysis and programming requests in close collaboration with statistical, modeling and clinical colleagues, retrieve the required data, and then transform the data into analysis (ADaM) datasets for further statistical analysis and reporting or modeling needs. The programming analyst will partner with statisticians to solve problems; reduce the amount of programming task being completed by statisticians to facilitate an increase in efficiency and compliance for statistical analyses. The programming analyst will also write programs to analyze data with statistical methods which are not currently available through commercial software packages.
- 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 datasets, tables, listings, figures and associated documentation
- Support the development of programming standards to enable efficient and high quality production of programming deliverables
- Create specifications for ADaM (analysis) datasets
- Review study deliverables to ensure that they are in compliant with company standards and SOPs
- Create electronic submission ready deliverables
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS/R 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/R programming experience in a clinical trial environment
Required Experience and Skills:
- Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH
- Designs and develops complex programming algorithms
- Experience in CDISC SDTM and ADaM standards
- 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.
- 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
- Demonstrated success in the assurance of deliverable quality and process compliance
- 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
- Ability to anticipate stakeholder requirements
- 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 / compound level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders
Preferred Experience and Skills:
• Oncology programming experience
• Experience in pharmacokinetic data programming
• Familiarity with clinical pharmacology and pharmacokinetics concepts
• 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 in process improvement
• Active in professional societies
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
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Job: Statistical Programming
Employee Status: Regular
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck