Biostatistics, Data Management Related Jobs

Jobs - Julie Bukar - Founder - JGB BioPharma Consulting Inc

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1) Sr. Statistical Consultant w/SAS Programming Skills – 6 month contract (New Jersey) 961

2) Statistical Programmer (SAS) – 6 month contract (New Jersey) 345


1) Sr. Statistical Consultant w/SAS Programming Skills – 6 month contract (New Jersey) 961

DESCRIPTION:

A statistician with strong programming skills being sought for the following:

  • Writing statistical analysis plans, summarizing clinical study data, contributing statistical sections to a final study report (including table and listing appendices, report results sections, graphs, etc.) and IND Annual Safety Reporting.
  • Creating, managing and maintaining the programming specifications for the analysis datasets utilizing company tools and methodologies.
  • Analyzing clinical study data, ensuring programming code meets regulatory and company standards and are consistently structured to permit efficient programming and reporting.
  • Performing quality assurance procedures on work performed by others.
  • Candidate will also work with the team to resolve reporting issues, trouble-shooting of complicated analysis rules, proactive identification of problems, and attend study meetings as needed.

EXPERIENCE AND QUALIFICATIONS:

  • Must have excellent communication skills and work well in a study team environment that includes other SAS programmers, data managers, clinical, and regulatory colleagues.
  • Experience coordinating work assignments with a CRO is a plus.
  • Pharmaceutical research oncology experience in the US is a plus.
  • A PhD or MS in Statistics with at least 3 years pharmaceutical experience in an FDA regulated environment covering Phases II-IV.

To apply for a position send your resume to Jobs@JGBBioPharma.com

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2) Statistical Programmer (SAS) – 6 month contract (New Jersey) 345

DESCRIPTION:

Provide statistical programming expertise in SAS for the production of analyses, tabulations, graphics, and listings from clinical trial data.

Key responsibilities and skills include, but are not limited to, the following:

  • Contribute to the preparation of analysis plans.
  • Prepare, document and test required programs and procedure data displays in an efficient manner for inclusion in integrated clinical, statistical reports and other similar reports.
  • Contribute to the integrated clinical/statistical report and other similar documents.
  • Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting.
  • Perform quality assurance procedures on work performed by others.
  • Develop, test, validate, document, maintain and execute software and/or systems using the currently endorsed tools or support of production activities.
  • Assist in the integration of data from remote entry sites, contract organizations and co-licensing partners to the central database.
  • Therapeutic area is internal medicine

EXPERIENCE AND QUALIFICATIONS:

  • Understands the basic skills and goals of reporting clinical data.
  • Writing knowledge of SAS; SQL and UNIX.
  • Proven ability to organize workload and priorities and complete tasks on time.
  • Demonstrated ability to work effectively in a team environment.
  • Strong interpersonal skills and ability to communicate effectively.
  • Ability to identify and solve technical problems.
  • Experience in CDISC Version 2,3 preferred.
  • Strong experience in SAS analytical database design is required.
  • Must have a science degree and 2+ years working in a pharmaceutical/research environment.
  • Advanced degree in Science or Mathematics

To apply for a position send your resume to Jobs@JGBBioPharma.com

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