Principal SAS ProgrammerKatalyst Healthcares and Life Sciences • Minneapolis, MN, United States
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Principal SAS Programmer
Katalyst Healthcares and Life Sciences • Minneapolis, MN, United States
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job_description.job_card.job_descriptionPhD or MS degree in Statistics, Biostatistics or related field. 5+ years of relevant work experience in CRO, biotech, pharmaceutical, or life sciences industry. Familiarity with clinical trial design and analysis activities and knowledge of regulatory guidelines (FDA / EMA, ICH / GCP). Experience with NDA / BLA submission activities. Experience in statistical programs such as Statistical Analysis System (SAS), CDISC and SDTM. Maintain awareness of industry standards, regulatory requirements, departmental guidelines, and Standard Operating Procedures (SOP's). Excellent organizational skills, time management, ability to prioritize workload, and meet deadlines. Excellent communication and interpersonal skills to effectively interact with others.
Responsibilities :
- The Principal SAS Programmer will be responsible for statistical programming for the client's clinical studies.
- In this role, you will develop and validate SAS programs for data presentation, analyses, and provide programming support to project team members.
- Our Ideal candidate will have a strong work ethic capable of thriving in a high growth, fast paced and intellectual environment.
- Serves as lead programmer for assigned projects to provide statistical and programming support in one or more Phase I-III clinical studies.
- Design and perform quality checks on analysis datasets, tables, listings, figures (TFL), and written reports to support clinical trial results using SAS.
- Create and review annotated CRF to STDM datasets.
- Produce and maintain technical programming specification documents.
- Lead and actively participate in client and project review meetings.
- Communicate with clients regarding study protocol or statistical analysis issues.
- Validate statistical deliverables and ensure that appropriate statistical methods are utilized.
- Ensure adherence to industry standards and regulatory requirements.
- Facilitate the development and application of adequate statistical methods in clinical research.
Requirements :
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Programmer • Minneapolis, MN, United States
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