Assoc Prin. Scientist Statistical Programming, Late-Stage (Hybrid)
Merck
6 hours ago
Remote friendly (North Wales, PA)
United States
Clinical Research and Development
Primary Activities
- Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices
- Maintain and manage a project plan including resource forecasting
- Coordinate the activities of a global programming team that includes outsource provider staff
- Membership on departmental strategic initiative teams
Education 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+ years SAS programming experience in a clinical trial environment
Required Skills and Experience
- Excellent interpersonal skills; 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; program-level leadership; ensures consistency; directs development of others; engages key stakeholders
Position Specific Required Skills and Experience
- Significant expertise in SAS and clinical trial programming (data steps, procedures, SAS/MACRO, SAS/GRAPH) plus systems and database expertise
- Experience leading large/complex statistical programming projects, coordinating programming team activities
- US and/or worldwide drug or vaccine regulatory application submission experience at leadership level, including electronic submission deliverables
- Design and development of complex programming algorithms
- Ability to comprehend analysis plans; understanding of statistical terminology and concepts
- Familiarity with clinical data management concepts
- Experience with CDISC and ADaM standards
- Demonstrated success in assuring deliverable quality and process compliance
- Strategic thinking; design statistical databases to optimize analysis/reporting using standards and best practices
- Ability to anticipate stakeholder requirements
Preferred Skills and Experience
- Experience with at least one other software than SAS (e.g., R, Python, NonMem)
- Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
- Experience providing technical/programming guidance and mentoring
- Ability and interest to work across cultures and geographies
- Ability to complete deliverables using global outsource partner programming staff
- Experience developing/managing project plan using Microsoft Project or similar
- Active in professional societies
- Experience in process improvement
Required Skills (from posting)
- CDISC Standards, Clinical Development, Clinical SAS Programming, Clinical Trials, Computer Programming, Data Management, Data Modeling, Project Management, Project Planning, Regulatory Submissions, Statistical Analysis, Statistical Programming, SDTM, Submission Management
Application
- Apply via https://jobs.merck.com/us/en (deadline stated on the posting)
- Requisition ID: R393801
- Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices
- Maintain and manage a project plan including resource forecasting
- Coordinate the activities of a global programming team that includes outsource provider staff
- Membership on departmental strategic initiative teams
Education 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+ years SAS programming experience in a clinical trial environment
Required Skills and Experience
- Excellent interpersonal skills; 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; program-level leadership; ensures consistency; directs development of others; engages key stakeholders
Position Specific Required Skills and Experience
- Significant expertise in SAS and clinical trial programming (data steps, procedures, SAS/MACRO, SAS/GRAPH) plus systems and database expertise
- Experience leading large/complex statistical programming projects, coordinating programming team activities
- US and/or worldwide drug or vaccine regulatory application submission experience at leadership level, including electronic submission deliverables
- Design and development of complex programming algorithms
- Ability to comprehend analysis plans; understanding of statistical terminology and concepts
- Familiarity with clinical data management concepts
- Experience with CDISC and ADaM standards
- Demonstrated success in assuring deliverable quality and process compliance
- Strategic thinking; design statistical databases to optimize analysis/reporting using standards and best practices
- Ability to anticipate stakeholder requirements
Preferred Skills and Experience
- Experience with at least one other software than SAS (e.g., R, Python, NonMem)
- Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
- Experience providing technical/programming guidance and mentoring
- Ability and interest to work across cultures and geographies
- Ability to complete deliverables using global outsource partner programming staff
- Experience developing/managing project plan using Microsoft Project or similar
- Active in professional societies
- Experience in process improvement
Required Skills (from posting)
- CDISC Standards, Clinical Development, Clinical SAS Programming, Clinical Trials, Computer Programming, Data Management, Data Modeling, Project Management, Project Planning, Regulatory Submissions, Statistical Analysis, Statistical Programming, SDTM, Submission Management
Application
- Apply via https://jobs.merck.com/us/en (deadline stated on the posting)
- Requisition ID: R393801