Overview
On Site
Full Time
Skills
Clinical Research
Biostatistics
Pharmaceutics
Life Sciences
Clinical Trials
Google Cloud Platform
Google Cloud
NDA
Statistics
SAS
CDISC
SDTM
Standard Operating Procedure
SOP
Organizational Skills
Management
Communication
Job Details
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.
- 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/Google Cloud Platform).
- 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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