Associate Principal Statistical Programmer – Early Stage Development, Pharmacokinetic/Pharmacodynamic Modeling and Simulation
MSD
full-time
Posted on:
Location Type: Hybrid
Location: North Wales • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $139,600 - $219,700 per year
Job Level
JuniorMid-Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
SAS programmingstatistical analysisdata preprocessingdata manipulationprogramming standardsclinical trial programmingCDISC SDTMADaM standardsstatistical methodsprogrammatic traceability
Soft skills
interpersonal skillscollaborationnegotiationwritten communicationoral communicationpresentation skillsproject managementleadershipstrategic thinkingproblem-solving
Certifications
BA/BS in Computer ScienceBA/BS in StatisticsBA/BS in Applied MathematicsBA/BS in Life SciencesBA/BS in EngineeringMS in Computer ScienceMS in StatisticsMS in Applied MathematicsMS in Life SciencesMS in Engineering