Senior Statistical Programmer
Location
Poland
Posted
63 days ago
Salary
zł200K - zł278K / year
Seniority
Senior
Job Description
Senior Statistical Programmer
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 • Assess 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
- In-depth understanding of clinical data structure (e.g., CDISC standards) and relational databases
- 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
- Good understanding of regulatory, industry, and technology standards and requirements
- 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
- In addition to base salary, some roles may be eligible for participation in Parexel’s annual performance-based bonus plan
- Annual salary review
- Total rewards incentives
- Fully flexible work arrangement
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