Senior Statistical Programmer
Parexel
Job Overview
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Job Description
Senior Statistical Programmer at Parexel
Parexel is actively seeking a Senior Statistical Programmer to join our team in Hungary, dedicating expertise to a single sponsor. This role provides technical leadership in clinical trials, acting as a subject matter expert. You will independently manage programming activities essential for the analysis and reporting of clinical study data.
Your Role at Parexel
- Create SAS programs for generating derived analysis datasets and content for tables, listings, and figures.
- Perform programming validation to ensure the quality of analysis datasets and programming outputs.
- Provide programming support for project teams, including developing programming strategies, standards, specifications, and programmed analysis.
- Support electronic submission preparation and review.
- Review key planning documents, such as statistical analysis plans and data presentation plans, to ensure alignment with development team objectives and clarity of programming requirements.
- Assess the impact of programming activities on project timelines and deliverables.
- Interact with vendors regarding project standards, programming conventions, specifications, and file transfers.
- Provide leadership in ensuring quality deliverables by consistently applying standards and complying with regulatory requirements, guidance, and corporate SOPs.
- Identify opportunities for increased efficiency and consistency within the team and in interactions with strategic vendors.
- Independently lead and/or perform programming assignments with minimal supervision.
- Support and contribute to improvement initiatives.
What You'll Bring
- Bachelor’s degree in statistics, biostatistics, mathematics, computer science, or life sciences.
- Proficiency in SAS programming.
- Minimum of 5 years of clinical/statistical programming experience within pharmaceutical clinical development.
- Demonstrated proficiency in analytical programming.
- In-depth understanding of clinical data structure, including CDISC standards and relational databases.
- Demonstrated skills in using software tools and applications such as MS Office, XML, and 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.
- Demonstrated ability to work effectively in a team environment with clinical team members.
About Parexel
Join a highly qualified and dynamic team within a multinational working environment. We offer a smooth induction and training program, competitive financial packages, and continuous development opportunities. Expect exciting professional challenges balanced with a healthy work/life balance, as we prioritize your welfare as much as that of our patients.
Parexel embraces a fully flexible work arrangement, allowing you to be entirely home-based. If you live near our office and wish to use it, you are always welcome, and we will have a desk ready for you!
Key skills/competency
- SAS Programming
- Clinical Data Analysis
- CDISC Standards
- SDTM/ADaM
- Statistical Programming
- Data Validation
- e-Submission
- Clinical Trials
- XML
- Relational Databases
How to Get Hired at Parexel
- Research Parexel's culture: Study their mission, values, recent news, and employee testimonials on LinkedIn and Glassdoor to understand their patient-centric approach and commitment to clinical excellence.
- Tailor your resume and cover letter: Highlight your extensive experience in SAS programming, CDISC standards (SDTM, ADaM), and clinical trial support, directly aligning with the Senior Statistical Programmer role's requirements at Parexel.
- Master technical programming concepts: Be prepared to discuss your expertise in creating and validating SAS programs for derived datasets, tables, listings, and figures, with a strong focus on data integrity and regulatory compliance.
- Showcase problem-solving and collaboration: During interviews, articulate specific examples of how you've solved complex programming challenges, led initiatives, and collaborated effectively with clinical teams and vendors at Parexel.
- Demonstrate understanding of the FSP model: Emphasize your ability to provide dedicated support to a single sponsor, showcasing adaptability and client-focused service for a Senior Statistical Programmer position at Parexel.
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