Associate Principal Scientist, Statistical Programming

Merck•Rahway, NJ

13d•$142,400 - $224,100•Remote

About The Position

Support statistical programming activities for multiple and/or late-stage drug/vaccine clinical development projects. Develop and execute statistical analysis and report 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. Responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research, and safety evaluation. Collaborate with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables. Serve as the statistical programming point of contact and knowledge holder through the entire project life cycle. Analyze 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 outsourced provider staff. Be a member of departmental strategic initiative teams.

Requirements

Bachelor’s degree or equivalent in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Pharmaceuticals, or a closely related field and 9 years of experience in the position offered or a related role; or a Master’s degree or equivalent in the aforementioned fields and 7 years of experience in the position offered or a related role.
Requires 7 years of experience in all of the following: SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; leading large and/or complex statistical programming projects that include coordinating the activities of a programming team; designing and developing complex programming algorithms; clinical data management concepts and ways of working with data management systems and processes; CDISC and ADaM standards; assuring deliverable quality and process compliance; turning strategy into tactical activities; anticipating stakeholder requirements; U.S. and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables; comprehending analysis plans which may describe methodology to be programmed; statistical terminology, models, and concepts; and designing statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.

Responsibilities

Support statistical programming activities for multiple and/or late-stage drug/vaccine clinical development projects.
Develop and execute statistical analysis and report 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.
Responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research, and safety evaluation.
Collaborate with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables.
Serve as the statistical programming point of contact and knowledge holder through the entire project life cycle.
Analyze 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 outsourced provider staff.
Be a member of departmental strategic initiative teams.