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Senior Statistical Programmer - Remote
Company | Precision For Medicine |
Address | Canada |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-08-19 |
Posted at | 10 months ago |
Why should you considering joining us? Because Precision for Medicine is not your typical CRO. As a member of our thriving team, opportunities to work with leading subject matter experts who understand the rare disease patient mindset and experience will surround you. We help translate science into success for rare disease patients with a targeted, patient-centric approach over a wide geographic area. We are specialists who tackle unusual problems in our detailed approach throughout every phase. From the beginning, we have nurtured a culture where patients’ needs and the needs of our valued clients come first. We focus in an environment where the quality of our work is the best, and where our employees can thrive, while still having fun and giving back to the patient community.
- You are comfortable interpreting, communicating and presenting statistical results to non-statisticians providing explanations and answering the statistical or clinical questions to non-statisticians in simple terms
- You thrive in a fast paced environment while maintaining a high level of quality
- You have excellent written and verbal communication skills
- You are passionate about health care solutions in rare disease and oncology
- You love working on a team and providing collaborative input to others, working well with data and project management
- You are a strong SAS programmer, experienced in supporting the analysis of clinical trial data
- Generate SDTM domains, ADaM datasets, and Define.xml files
- Program, test, and document global utility programs and tools in accordance with standards and validation procedures
- Program analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS
- Serve as the primary project team representative, delegating work as appropriate
- Provide technical oversight and leadership in the areas of analysis and reporting
- Review, maintain, and approve study documents per standard procedures
- Participate in the development and/or maintenance of departmental procedures and standards
- Create specifications for derived/analysis datasets
- Review output across programs to ensure consistency
- Assist in creation of table mockups under supervision of statisticians
- Perform quality control for SAS programs and other study documents (e.g., presentations and reports)
- Document the quality control review process
- Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
- Train and mentor new programmers
- Principal Statistical Programmer: Minimum 8 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial Statistical Programmer
- Senior Statistical Programmer: 5-7 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial Statistical Programmer
- Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
- Excellent communication and interpersonal skills to effectively interface with others
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
- Base SAS®, SAS/STAT and SAS/ACCESS software
- Proficient in SAS Macro Programming
- Advanced computer skills
- SAS Certified Advanced Programmer for SAS 9 or equivalent proficiency
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