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Quintiles

Sr. Statistical Programmer (Nationwide - Permanent) - Novella Clinical

Novella Clinical is searching for a permanent Sr. or Principal Statistical Programmer.

BASIC FUNCTIONS:

Develop and validateSAS programs to perform data presentation and analysis. Provideprogramming support to project team members and other StatisticalProgrammers. Perform Statistical Programmer lead responsibilities onmultiple projects (number of concurrent projects and study complexity levelwill vary based on seniority level).

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Project Team Lead Responsibilities:

  • Review and providefeedback on Master Plan for assigned project.
  • Review and providefeedback on QC Validation Plan.
  • Review and provideinput to project timelines, and ensure that project timelines are met for bothinternal and external clients.
  • Attend StatisticalAlignment meeting.
  • Assume responsibilityfor project study budget, and perform monthly time projections for eachproject.
  • Attend internal teammeetings and relevant client team meetings as needed.
  • Archive relevantdocumentation and deliverables.
  • Review and providecomments on statistical analysis plan and data display documents.
  • Manage programmingeffort for deliverables, including coordination of programming activity amongteam of assigned programmers, tracking programming effort, handling installation documentation, facilitating communication with the other teammembers.
  • Filecode/output/documentation associated with client delivery to defined electronic folder structures on an ongoing basis, and perform final archival activity atstudy close.
  • Ensure that projecttasks are completed with acceptable quality for both internal and externalclients.

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StatisticalProgramming responsibilities:

Review and providecomments on programming specifications for analysis data sets and tables/listings/figures.

Review statisticalanalysis plan and data display documents as needed, to provide feedback onprogramming feasibility and efficiency.

Develop and/orvalidate analysis data sets and tables/listings/figures.

Perform function ofun-blinded statistical programmer for relevant studies including management ofun-blinded programming, installation and validation activities; filing un-blindedcode/output/documentation; and maintaining security of restricted files.

Otherresponsibilities:

Contribute to processimprovement initiatives.

Perform independentcode review and unit testing (as needed) and utilize source code managementsoftware

Develop QC test plansand complete documentation for SAS code installs in QC and Productionenvironments as needed for Statistical Programming activities.

Perform other dutiesthat may be requested by management as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Understanding of GCP,ICH, and FDA guidelines and regulations applicable to conduct clinicalresearch.
  • Knowledge ofprogramming and validation methods, and software development life cycle.
  • Experience with SASBase, SAS Macro, and ODS as well as strong data step skills.
  • Experience withSAS/STAT and SAS/GRAPH.
  • Ability to performmultiple tasks efficiently and accurately with minimal supervision whilemeeting deadlines.
  • Ability to workindependently and as part of a team.
  • Ability to learn newprogramming languages, technology, tools and processes.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Understanding of GCP,ICH, and FDA guidelines and regulations applicable to conduct clinicalresearch.
  • Knowledge ofprogramming and validation methods, and software development life cycle.
  • Experience with SASBase, SAS Macro, and ODS as well as strong data step skills.
  • Experience withSAS/STAT and SAS/GRAPH.
  • Ability to performmultiple tasks efficiently and accurately with minimal supervision whilemeeting deadlines.
  • Ability to workindependently and as part of a team.
  • Ability to learn newprogramming languages, technology, tools and processes.

MINIMUM RECRUITMENT STANDARDS:

  • BS degree (or equivalent, based upon education and experience) in Computer Science, Mathematics, life/analytical sciences or related field, and 2 years of work experience in SAS programming, preferably in a clinical environment, or
  • Masters-level degree in Computer Science, Mathematics, life/analytical sciences or related field with a minimum of 1 year of work experience in SAS programming, preferably in a clinical environment.
  • Excellent communication, interpersonal, and organization skills, highly detail-oriented.

EEO Minorities/Females/Protected Veterans/Disabled

Job ID: b7cec100a35b1412830cadd78b0d1777
Employment Type: Other

This job is no longer available.

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