Job Description

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.

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