at Merck in Dover, Delaware, United States
Job Description
Job Description
In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
The Associate Principal Scientist, Statistical Programming-Oncology leads the statistical programming activities for multiple and/or large/complex late stage drug/vaccine clinical development projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. Key areas of focus include: (1) the assurance of deliverable quality and process compliance, (2) effective deliverable development utilizing global and therapeutic area (TA) standards that optimize analysis and reporting and promote a strategic knowledge-base data model, (3) maintaining and managing a project plan including resource forecasting, (4) coordinating the activities of a global programming team that includes outsource provider staff, and (5) membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development.
Additional Responsibilities
+ Design and maintenance of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation
+ Key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables
+ Serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle for assigned projects
Educational Qualifications:
+ BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9-12 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
Required Experience and Skills:
+ Directing large and/or complex statistical programming projects that include coordinating the activities of a programming team
+ Expansive 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, MACRO, SAS/GRAPH; systems and database expertise | Familiarity with statistical analysis methods and clinical data management concepts
+ United States and/or worldwide drug or vaccine regulatory application submission knowledge at the leadership level including the development of electronic submission deliverables.
+ Strategic, effective and strong project management skills
+ Program Leader who establishes 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
+ Comprehension of statistical terminology and concepts Designs and develops complex programming algorithms
+ Principled and effective 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
+ CDISC and ADaM standards skills
+ Demonstrated success in the assurance of deliverable quality and process compliance
+ Ability to anticipate stakeholder and regulatory requirements
Preferred Experience and Skills:
+ Strong working knowledge of reporting processes, standard operating procedures (SOPs) and software development life-cycle (SDLC)
+ Ability and interest to work across cultures and geographies
+ 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
+ Developing and managing a project plan using Microsoft Project or similar package
+ Active in professional societies
+ Process improvement
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