Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- 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:
- PhD 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.
- Understanding of Ultra Compare software.
- 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.