Senior Scientist, Statistical Programming

MSD • North Wales, PA

1d

About The Position

Support statistical programming activities for clinical trial data analysis. Develop SAS programs to create and validate analysis datasets (ADaM) and summaries (TFLs) in support of Clinical Study Reports and regulatory submissions (FDA, EMA, etc.). Collaborate with biostatisticians, project leads, and other stakeholders in ensuring project plans are executed efficiently with timely and high-quality deliverables. Develop effective study and report programming and validation utilizing global CDISC, ICH, and Therapeutic Areas standards and following departmental SOPs and good programming practices. Maintain and manage a project plan including resource forecasting. Coordinate activities of a global programming team. Participate in departmental strategic initiative teams.

Requirements

• Master’s degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biomedical Engineering, or a closely related field and 3 years of experience in the position offered or a related role; OR a Bachelor's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biomedical Engineering, or a closely related field and 5 years of experience in the position offered or a related role.
• 3 years of experience with all the following: Developing analysis and reporting deliverables for Phase 2 and 3 clinical trials, including creation of analysis datasets, tables, graphics, and listings, for planned and unplanned analyses.
• 3 years of experience with SAS programming in a clinical trial environment including data step and procedures, macros, graphics, ODS.
• 3 years of experience interpreting and executing on clinical trial statistical analysis plans.
• 3 years of experience utilizing CDISC standards to create ADaM and SDTM datasets.
• 3 years of experience designing and developing complex programming algorithms.
• 3 years of experience ensuring process compliance and deliverable quality.

Responsibilities

• Support statistical programming activities for clinical trial data analysis.
• Develop SAS programs to create and validate analysis datasets (ADaM) and summaries (TFLs) in support of Clinical Study Reports and regulatory submissions (FDA, EMA, etc.).
• Collaborate with biostatisticians, project leads, and other stakeholders in ensuring project plans are executed efficiently with timely and high-quality deliverables.
• Develop effective study and report programming and validation utilizing global CDISC, ICH, and Therapeutic Areas standards and following departmental SOPs and good programming practices.
• Maintain and manage a project plan including resource forecasting.
• Coordinate activities of a global programming team.
• Participate in departmental strategic initiative teams.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior