Statistical Programmer

Internal/extrernal stakeholders, project team members, vendors
- Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs
- Provides programming support for project teams, including development of programming strategies, standards, specifications and programmed analysis
- Support the electronic submission preparation and review
- Reviews key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities
- Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers
- Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors
- Independently leads and / or performs programming assignments with mínimal supervision
- Support improvement initiatives

Minimum Requirements:

- Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
- At least 3 years programming experience in industry recommended.
- For US positions: US military experience will be considered towards industry experience.
- Demonstrated proficiency in using SAS, R or other programming languages to produce derived analysis datasets and TFLs.
- Understanding of clinical data structure (e.g. CDISC standards) and relational database.
- Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM.
- Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission.
- Have good understanding of regulatory, industry, and technology standards and requirements.
- Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs.
- Demonstrated ability to work in a team environment with clinical team members.

Preferred Requirments:

- Minimum of 3 years clinical / statistical programming experience within pharmaceutical clinical development
- Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements
- Experience in other software packages (e.g. R)
- Experience with the Linux operating system