Associate Principal Scientist, Statistical Programming

Merck•Rahway, NJ

1d•$144,373 - $224,100•Onsite

About The Position

Lead statistical programming activities for multiple and/or complex late-stage clinical trial development programs. Develop and execute 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. Act as a key collaborator with biostatisticians, project leads, data managers, and other 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 product lifecycle. Develop SAS and R programs to create and validate analysis datasets (ADaM) and summaries (TFLs) in support of clinical study reports and regulatory submissions (FDA, EMA, etc.). Responsible for assurance of deliverable quality and process compliance. Develop and maintain macro libraries (global and project-specific). Maintain and manage a project plan including resource forecasting. Coordinate activities of a global programming team that includes outsource provider staff. Act as a member on departmental strategic initiative project teams such as new statistical computing platform evaluation and development.

Requirements

Bachelor’s degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Pharmaceutical Sciences, or related field plus at least 9 years experience in Statistical Analysis System (SAS) programming in a clinical trial environment OR a Master’s degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Pharmaceutical Sciences, or related field plus at least 7 years experience in Statistical Analysis System (SAS) programming in a clinical trial environment.
Experience leading large and/or complex statistical programming projects for Phase 2 and 3 clinical trials, including coordinating the activities of a programming team.
US and/or worldwide drug regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
Broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables for clinical trials (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements.
Expertise in CDISC and ADaM standards.
Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.
Must possess strong familiarity with statistical analysis methods and clinical data management concepts.
Strong project management skills; demonstrated ability as a program leader.
Ability to determine appropriate programming methodology, assure programming consistency across protocols and projects, complete programming tasks, and direct the program development effort of other programmers.
Demonstrated success in the assurance of deliverable quality and process compliance.
Must be an experienced programming mentor.
Possess ability to engage key stakeholders.
Must possess ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed; an understanding of statistical terminology and concept designs and develop complex programming algorithms.
Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration.
Ability to deal well with change and seamlessly assimilate to new projects and stakeholders.
Strategic thinking ability to turn strategy into tactical activities.
Design statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.
Ability to anticipate stakeholder and regulatory requirements.

Responsibilities

Lead statistical programming activities for multiple and/or complex late-stage clinical trial development programs.
Develop and execute 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.
Act as a key collaborator with biostatisticians, project leads, data managers, and other 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 product lifecycle.
Develop SAS and R programs to create and validate analysis datasets (ADaM) and summaries (TFLs) in support of clinical study reports and regulatory submissions (FDA, EMA, etc.).
Responsible for assurance of deliverable quality and process compliance.
Develop and maintain macro libraries (global and project-specific).
Maintain and manage a project plan including resource forecasting.
Coordinate activities of a global programming team that includes outsource provider staff.
Act as a member on departmental strategic initiative project teams such as new statistical computing platform evaluation and development.