Associate Director providing epidemiological insights for health and treatment outcomes at Pfizer. Conducting literature reviews and overseeing safety studies and regulatory submissions.
MS
Hybrid Associate Principal Scientist, Statistical Programming – Late-Stage
Posted 3 months ago
About the role
- Associate Principal Scientist supporting statistical programming activities for drug/vaccine clinical development projects. Ensure timely and high-quality deliverables while collaborating with global teams.
Responsibilities
- support statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects
- development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures)
- design and maintenance of statistical databases
- ensure that project plans are executed efficiently with timely and high-quality deliverables
- serve as the statistical programming point of contact and knowledge holder throughout the product lifecycle
- assurance of deliverable quality and process compliance
- effective deliverable development utilizing global and TA standards
- maintaining and managing a project plan including resource forecasting
- coordinating the activities of a global programming team that includes outsource provider staff
- membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development
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
- Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team
- Broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements
- Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
- Familiarity with statistical analysis methods and clinical data management concepts
- US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables
- Strong project management skills; A program leader; Determines appropriate programming methodology, assures programming consistency across protocols and projects, completes programming tasks, and directs the program development effort of other programmers; an experienced programming mentor; ability to engage key stakeholders.
- Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed; Understanding of statistical terminology and concepts Designs and develops complex programming algorithms.
- Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders.
- 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.
- Experience in CDISC and ADaM standards.
- Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC).
- Ability and interest to work across cultures and geographies.
- Experience providing technical and/or programming guidance and mentoring to colleagues.
- Ability to complete statistical programming deliverables through the use of global outsource partner programming staff.
- Experience developing and managing a project plan using Microsoft Project or similar package.
- Active in professional societies.
- Experience in process improvement.
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
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