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Senior Statistical Programmer – FSP
Location
Hungary
Posted
139 days ago
Salary
0
Seniority
Senior
Job Description
Senior Statistical Programmer – FSP
Parexel
• 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. • Provides leadership for ensuring quality of deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices. • Identifies opportunities for increased efficiency and consistency within team and our interactions with strategic vendors. • Independently leads and / or performs programming assignments with minimal supervision. • Support improvement initiatives.
Job Requirements
- Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required.
- Proficiency in SAS.
- Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development.
- Demonstrated proficiency in analytical programming.
- Have in-depth understanding of clinical data structure (e.g., CDISC standards) and relational database.
- Demonstrated skills in using software tools and applications, e.g., MS office, XML, Pinnacle 21.
- 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.
Benefits
- Competitive financial packages
- Training and development
- Fully flexible work arrangement
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