Senior Statistical Programmer
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Job Description
Senior Statistical Programmer providing technical expertise and programming support for clinical trials at Parexel, a leading global clinical research organization.
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 and clarity and completeness of programming assumptions and requirements; assess impact on programming activities.
- Interact with vendors regarding project standards, programming conventions, programming specifications and file transfers.
- Provide leadership for ensuring quality of deliverables by consistently 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 our interactions with strategic vendors.
- Independently lead and / or perform programming assignments with minimal supervision.
- Support improvement initiatives.
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 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:
- Annual performance-based bonus plan
- Annual salary review
- Total rewards incentives
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