Job Details

  • Title: Clinical Application Specialist
  • Code: RCI-07656
  • Location:
  • Posted Date: 02/14/2020
  • Duration: 12 Months
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  Job Description

Description:

Strong SAS graphic experience is needed

  • Excellent communication skill
  • Knowledge of regulatory submission process, experience on creating ISS, ISE ADaM datasets and TLFs is a plus.
  • Experience on creating ADaM data specifications such as specification for ADAE dataset.
  • 8+ Years SAS Programming Experience supporting Phase 1-3 clinical trials in CRO or pharmaceutical industry.
  • Solid understanding of SDTM and ADaM implementation guidance, minimum 6 years of work experience on creating and validating ADaM datasets.
  • Experience on creating Tables, Listing and Figures for clinical study report using proc report or data _null_.
  • Efficient in using Excel and Word documents.
  • There is a possibility for someone to work remote for the right person
NOTES FROM MANAGER:

What hours and days will this person be working? Core business hours Monday thru Friday
What are the top 5 skills/requirements this person is required have?
a. Required Skill 1: 8+ Years SAS Programming Experience supporting Phase 1-3 clinical trials in CRO or pharmaceutical industry.
b. Required Skill 2: Solid understanding of SDTM and ADaM implementation guidance, minimum 6 years of work experience on creating and validating ADaM datasets.
c. Required Skill 3: Excellent Communication
d. Required Skill 4: Experience on creating Tables, Listing and Figures for clinical study report using proc report or data _null_.
e. Required Skill 5: Knowledge of regulatory submission process, experience on creating ISS, ISE ADaM datasets and TLFs is a plus.
What years of experience is required?
5+ years for Wenyun’s late phase Oncology, including 2+ years of oncology experience. Must have Immunology therapuetic area, the other positions do not have specific therapeutic area requirement.
What level of education and/or certification is required?
Bachelors Degree,
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
Survival analysis experience is a plus. R experience is also a plus.
What is the environment that this person will be working in (i.e. group setting vs individual role)?
Both
Is any testing required for this role?
CCT training
Does this position offer the ability to work remotely on a regular basis or is it an on-site role?
If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? Remote for the qualified candidate with good communication skills,