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Senior Biostat Programmer

Location: Woodcliff Lake, NJ, United States
Job Type: Contract
Job Category: Pharmaceutical and Biotech
Job Industry: Pharmaceuticals and Medical Products
Salary: The pay we're offering is $60 - $80 per hour
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The Opportunity


We're looking for a Senior Biostat Programmer, working in Pharmaceuticals and Medical Products industry in 155 Tice Boulevard, Woodcliff Lake, New Jersey, 07677, United States.

  • Providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas.
  • Analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications).
  • Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files).
  • Working with external vendors in order to develop or monitor the content and structure of SAS data sets.

Our Client

Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.

Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.

Experience Required for Your Success

  • Minimum of Bachelors degree in Statistics, Computer Science, Mathematics, or a related science discipline (Masters preferred. Strong educational background is expected)
  • Minimum 8 years experience in SAS programming in biostatistics department environment for phase I-IV clinical trials in a pharmaceutical/CRO environment
  • Lead Programmer experience is expected
  • Strong managerial / technical understanding of programming and clinical related issues along with an ability to demonstrate significant leadership of SAS programming technical activities in a clinical pharmaceutical/CRO environment
  • Understanding of submission-related activities and experience with agency-related requirements expected. Define.XML knowledge and familiarity with a submission process is preferred
  • Oncology and in-depth ADaM programming required
  • Submission support with compliance is expected
  • Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office
  • Knowledge of SDTM and ADaM standards
  • 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.
  • Proactive and effective working
  • Accountable
  • Leadership expected
  • Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment, managing that team as required

What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply Now

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