Senior Scientist, Statistical Programming

Job Description

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.

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.

• Must have 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.

  • SAS programming in a clinical trial environment including data step and procedures, macros, graphics, ODS.

  • Interpreting and executing on clinical trial statistical analysis plans.

  • Utilizing CDISC standards to create ADaM and SDTM datasets.

  • Designing and developing complex programming algorithms.

  • Ensuring process compliance and deliverable quality.

Required Skills:

 Preferred Skills:

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