Senior Statistical Programmer – FSP
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Job Description
Senior Statistical Programmer at Parexel providing technical expertise in clinical trials and programming activities. Working remotely in Poland or Serbia for a dedicated sponsor with a focus on quality deliverables.
Responsibilities:
- 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
- Provide programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis
- Support the electronic submission preparation and review
- Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives
- Ensure quality of deliverables by applying standards and complying with regulatory requirements, guidance, and corporate and departmental SOPs and work practices
- Identify opportunities for increased efficiency and consistency within team and interactions with strategic vendors
- Independently lead and/or perform programming assignments
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 software tools and applications, e.g., MS office, XML, Pinnacle 21
- Demonstrated ability in handling and processing 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
- Ability to work in a team environment with clinical team members
Benefits:
- Participation in Parexel’s annual performance-based bonus plan
- Annual salary review
- Total rewards incentives
- Flexible work arrangement
- Opportunity to develop within your role
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