Description:Experience in Oncology CLINICAL Statistician Description
Provide statistical expertise for study case report form design, database structure, analysis plan, and review of the study protocols and reports
Perform data analysis and provide statistical support including collaboration with medical groups to complete joint scientific reports and FDA overviews, including the review of such reports to ensure accuracy and clarity Must have clinical research experience
10+ Years Experience Level
Learn and maintain expertise in the use of the UNIX utilities developed for the Statistical Programmers
Participate in the development of new UNIX utilities and SAS macros
Responsible for the creation and accuracy of all submission datasets and analysis programs Ensure all SAS programs are imported into the archive system prior to the creation of the final output
Responsible for the accuracy of SAS programs by reviewing output, reviewing code, reviewing log files and running all checking utilities
Demonstrated a thorough understanding of SAS programming concepts and techniques
Review analysis output to ensure internal consistency with other output for various reports such to CSR, ISS, ISE,
Responsible for creating peer review programs for assigned studies
Responsible for the creation and accuracy of derivation programs for routine and complicated analyses, including peer review
Responsible for the creation of data definition documents and TOCs
Provide accurate and timely responses to routine requests from clients
What hours and days will this person be working?
[ST] In general, 40/hrs per week and M-F
What are the top 5 skills/requirements this person is required to have?
Required Skill 1: [ST] SAS
Required Skill 2: [ST] CDISC (Adam and SDTM)
Required Skill 3: [ST] Clinical Trial
Required Skill 4: [ST] Communication and time management
Required Skill 5: [ST] Unix
What years of experience, education, and/or certification is required?
[ST] 8+ with MS in Statistics or computer or 10+ and Bachelor’s in Statistics or computer
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
[ST] Experience working on regulatory submissions
What is the environment that this person will be working in (i.e. group setting vs individual role)?
[ST] will be group and individual
Is any testing required for this role?
Does this position offer the ability to work remotely on a regular basis or is it an on-site role?
If a remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? [ST] Prefer onsite but open for full (5 days) remote.
Other notable details from the hiring manager about this role[ST] In general we are looking for someone to come in and right off the bat, with minimum guidance, become a key player within the team.