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.
- 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.
Thanks!! With Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Direct: 732-662-7964 | (W) 732-549-2030 x 219
Inc. 5000 – 2007-2015 (9 Years in a row)
