The Senior Statistical Programmer I is responsible for producing and coordinating the SAS programs, output, study reports for clinical trial programs, independently perform quality control on the statistical outputs, and achieve First Time Right outputs. The Senior Statistical Programmer I ensure the assigned work is processed on time and at highest quality levels.

Key Responsibilities:

Develop and review specification for SDTM, ADaM, and Derived datasets.
Develop and validate programming for CDISC SDTM, ADaM, and derived datasets.
Develop and validate programming for integration of databases from multiple studies and sources.
Develop and validate programming, and documentation of statistical programs for use in creating statistical tables, figures, and listings.
Create and review define packages Define.xml, and reviewers guide RGs for SDTM, ADaM, and derived databases.
Perform, and plan the programming of database quality control checks.
Perform, and plan the programming for utility and project specific macros.
Plan and train junior team members.

Education:

Undergraduate/Bachelor s Degree required or equivalent experience; degrees in computer science, engineering, mathematics, or statistics are preferred.

Experience:

Minimum 5 years of relevant experience in a pharmaceutical, biotech, CRO, or regulatory agency
Exposure in working in different therapeutic areas
Good working knowledge in all phases of clinical trials
Familiar with CDISC standards, SDTM and ADaM data models and hands on experience in implementing these models

Skills:

Ability to present technical information to a non-technical audience proven ability to operate independently.
Excellent written and oral communication skills including grammatical/technical writing skills
Excellent attention and accuracy with details
Good Team player skills

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Senior Statistical Programmer I

Job Description

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