Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively.
Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
If you think you are the right match for the following opportunity, apply after reading the complete description.
Job Description
This position is responsible for supporting the phase 3 clinical trial , including but not limited to, as outlined below :
- Reviews SAP, TLG shells and variable derivation rules and provides feedback.
- Develops Study Quality Surveillance Plan and monitors study conduct to proactively address issues to ensure high quality study data.
- Develops the Data Monitoring Committee charter in collaboration with other functions and liaises with independent statisticians.
- Reviews the SAP, provides feedback to the statistician and develops (with the statistician) study specific dataset specs.
- Performs and validates statistical analysis.
- Independently reviews CSRs and performs data interpretation.
- Supports submission strategy planning, regulatory communication and development of Health Authorities responses.
Qualifications
- MS in Biostatistics / Statistics preferred, with at least 5 years of experience in the pharmaceutical, CRO or biotech industry.
- Strong SAS programming skills, with experience in SAS-Base, MACRO, STAT, and GRAPH.
- Strong CDISC data standards, e.g. SDTM and ADaM.
- Good technical writing skills.
- Good communication skills with strong verbal, written and interpersonal communication skills.
- Strong organizational skills with ability to effectively manage multiple projects.
- Strong teamwork ability / commitment and individual initiative.
- Proven experience with UNIX and Windows operating systems.
- Understanding of the software development life cycle.
- Understanding of FDA guidelines.
- Good organization, time management and attention to detail skills.
- Needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
- Applies good judgment and demonstrates initiative to resolve issues.
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