Senior Statistical Programmer will be responsible for supporting statistical programming activities for registrational and non-registrational studies. Represents Statistical Programming function on the study team and contributes towards developing, validating, and documenting software programs to meet the study needs. In this role, the programmer will be accountable for the implementation and delivery of complete and accurate data and reports to support regulatory submissions. Organizes and facilitates programming tasks to ensure timely study deliverables. Depending on the project complexity, the programmer may have primary ownership of one or more studies. The programmer will be responsible for mentoring junior level programmers and may have management responsibilities.

ESSENTIAL RESPONSIBILITIES:

• Functions as the primary point of contact for programming related tasks for assigned study.

• Under minimum guidance, develops and modifies SAS programs to analyze and evaluate clinical data along with assessing data accuracy and consistency.

• Develops all extraction programs to create raw datasets related to the study.

• Develops source and analysis datasets from raw data to support the analysis of clinical trials' data.

• Responsible for creating data specifications to generate source and analysis datasets as per the study requirements.

• Generates tables, listings, and figures to support clinical study reports and electronic submissions.

• Develops, validates, and maintains global tools such as SAS macros that increase the efficiency of the programming team.

• Provides programming support to supplemental or exploratory analyses for regulatory agencies or any other ad-hoc requests.

• Validates, documents, and archives single-use statistical software programs as per department SOPs under minimal guidance.

• Lead data discrepancy process within a study.

• Responsible for creating submission documents necessary to support submissions to regulatory agencies in electronic format.

• Review outputs to ensure consistency across programs within the study.

• Reviews and provides input for CRFs, edit check specifications, SAP, and TLF mock-ups.

• Review, maintain; and approve study documents per standard procedures.

• Uses discretion and independent judgment to consider and determine appropriate solutions/actions to a range of problems.

• Participate in the development and/or maintenance of departmental procedures and standards.

QUALIFICATIONS:

• Minimum: Bachelor's degree in a scientific discipline.

• Preferred: Master's degree in a scientific discipline.

• Minimum: 5 years' experience as a statistical programmer using SAS in pharmaceutical, biotechnology, diagnostics, or medical device environment.

• Preferred: 7 or more years' experience as a statistical programmer using SAS or other statistical analysis software such as R in pharmaceutical, biotechnology, diagnostics, or medical device environment.

• Must have knowledge of Base SAS, SAS/STAT, SAS macros, SAS/GRAPH, and SAS SQL Pass-Through Facility.

• Familiarity with statistical software, statistical analyses, and databases.

• Strong verbal and written communication skills.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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