Connecting linkedin

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9oyw1sew4td2lsbglhbxmvanbnl2jhbm5lci1kzwzhdwx0lwpvyi5qcgcixv0

Job

Principal Statistical Programmer

  • Location

    Southern California

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Emily Mato

  • Contact email:

    e.mato@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 2 months ago

  • Expiry date:

    2021-01-01

  • Startdate:

    ASAP

Scope

This is an opportunity to serve as a cross-functional leader and collaborate closely across Biostatistics, Clinical Data Management, Medical Affairs, Clinical, and Regultaory to support a robust oncology pipeline. 

Responsibilities

  • Create and implement programming plan in accordance with submission standards and clinical protocols
  • Develop SAS programs to produce quality and timely deliverables, including SDTM and ADaM datasets, define .xml, and tables
  • Conformance check SDTM and ADaM datasets
  • Identify and propose solutions for any issues
  • Ensure datasets are in compliance with submission standards
  • Lead programming team to create submission package
  • Manage, oversee, and review all CRO programming activities

Requirements

  • BS in Life Sciences, Statistics, Computer Science, or related field required
  • Advanced degree (MS or higher) strongly preferred
  • Minimum of 5 years experience in pharmaecutical/biotech drug development
  • Demonstrated expertise in CDISC standards, including SDTM and ADaM

My team and I are working on a variety of additional opportunities for a broad portfolio of clients across the US and internationally. If this role isn't for you but you would like to explore your options in the market, I would welcome a confidential conversation at your convenience. Please contact me at (619) 350-6149 or  e.mato@hamlynwilliams.com.