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Statistical Programmer
Ref No.: 18-14289
Location: Marlborough, Massachusetts
Start Date / End Date: 10/08/2018 to 03/29/2019
Job Title: Statistical Programmer
Duration: 6 months
Location:­ Marlborough, MA

Job Description:

Summary of Responsibilities:
Work as a statistical programmer on drug development project teams. Support the inferential analysis of key safety and efficacy endpoints from clinical trials. Primary responsibilities include the production of clinical trial deliverables (e.g.  analysis datasets and specifications, well-documented SAS® code, summary tables, figures, listings and analyses) for internal projects in support of internal biostatisticians, as well as providing validation and review of key results for external projects. Must be able to work in a standardized programming environment and communicate results and work product both verbally and in writing.

Essential Functions Required for Job:
1. Provide statistical programming representation on project teams – 5% (2 Projects).
Support internal biostatisticians in the production of clinical trial report deliverables, including analysis datasets and summary report outputs – 10%.
2. Provide validation and review services for internal and external projects. Write up and communicate findings, as necessary – 30%.
3. Write computer programs in SAS for the production or validation of clinical trial deliverables, and document the same, in a manner consistent with internal SOPs – 30% 
4. Prepare electronic and paper deliverables for submission to FDA in a manner consistent with FDA Guidance practices – 10%. 
5. Interact with other project team members, as necessary – 5%. 
6. Interact with external vendor personnel, as necessary – 10%.

KNOWLEDGE AND SKILLS:
Education level and/or relevant experience(s):
  • Bachelor or Masters level degree in Biostatistics, Statistics, or a related field. 
Experience:
  • 5+ years of pharmaceutical or biotech industry experience.
 Knowledge and skills (general and technical):
  • SAS® experience is a requirement.
  • Analytical Data Sets
  • Validation of CRO Partners
  • Production of clinical study report deliverables, including analysis datasets, summary tables, figures and listings are relevant qualifications for this position.
  • Experience with regulatory submission, electronic submissions, and relational database is desirable.
Complexity:
  • The individual in this position should have a demonstrated capability to deliver work product in a multi-project, team-oriented environment.                                     
Other requirements (licenses, certifications, specialized training, and physical or mental abilities required):
  • SAS® Certification is desirable.
  • CDISC training/experience is desirable.
  • Experience with electronic submission formats such as eCTD is desirable.
Shiva Prasad | Senior Recruiter
Sunrise Systems Inc.
Desk: (732) 272 0346
Email: shiva.p@sunrisesys.com | URL: www.sunrisesys.com
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