Associate Manager – Market Access, Life Sciences/Pharma
Beghou Consulting
PythonTableauVBA
Senior Scientist, Statistical Programmer – Late-Stage
MSD
full-time
Posted on:
Location: 🇺🇸 United States
Visit company websiteSalary
💰 $114,700 - $180,500 per year
Job Level
Senior
Tech Stack
Python
About the role
- Supports statistical programming activities for late-stage drug/vaccine clinical development projects
- Development and execution of statistical analysis and reporting deliverables (safety and efficacy analysis datasets, tables, listings, figures)
- Design and maintenance of statistical datasets supporting multiple stakeholder groups including clinical development, outcomes research and safety evaluation
- Serve as statistical programming point of contact and knowledge holder through entire product lifecycle for assigned projects
- Coordinate activities of a global programming team including outsource provider staff
- Maintain and manage project plan including resource forecasting
- Membership on departmental strategic initiative teams
- Ensure project plans are executed efficiently with timely and high-quality deliverables
- Develop and validate analysis and report programming utilizing global and TA standards and following SOPs and good programming practices
- Anticipate stakeholder requirements and design statistical databases optimized for analysis and reporting
Requirements
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment
- MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment
- Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH
- Preferred hands-on experience using R and Python for data analysis
- Experience developing analysis and reporting deliverables for Research & Development projects (data, analyses, tables, graphics, listings)
- Ability to comprehend analysis plans and understanding of statistical terminology and concepts
- Familiarity with clinical data management concepts
- Experience in CDISC and ADaM standards
- Experience ensuring process compliance and deliverable quality
- Experience in project leadership, coordinating global programming teams, and resource forecasting
- Experience with Microsoft Project or similar package
- Effective interpersonal, negotiation, written, oral, and presentation skills
- US and/or worldwide drug or vaccine regulatory application submission experience (preferred)
- Experience assuring programming consistency across protocols and projects; mentoring programmers
- Ability and interest to work across cultures and geographies
- Experience completing deliverables through global outsource partner programming staff
- Active in professional societies
- Experience in process improvement
