Principle Biostatistician Programmer, Medical affairs

Principle Biostatistician Programmer, Medical affairs

22 Jan 2024
California, Sanfrancisco, 94080 Sanfrancisco USA

Principle Biostatistician Programmer, Medical affairs

Vacancy expired!

Principle Biostatistician Programmer - Remote in San Francisco CA

Kelly FSP is currently seeking a Principle Biostat Programmer to support one of our global sponsor clients. This role is a full-time with no end date, offers our enhanced benefits package. As a Kelly employee within this group, you will be eligible for Medical, Dental, 401K and a variety of other benefits options to choose from. This includes paid time off, including holiday, vacation, and sick/personal time unless told otherwise.

This essential team member will be responsible for supporting the statistical programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of SAS programming standards and procedures.

  • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications.
  • Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files.
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Maintain complete and auditable documentation of all programming activities.
  • Review output across SAS programs to ensure consistency.
  • Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
  • Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
  • Participate in the development and/or maintenance of departmental procedures and standards.
  • Review CRFs, edit check specifications, and table mock-ups.
  • Works effectively with cross functional groups, study team, and vendors.
  • Participates in monitoring CRO activities and reviewing CRO deliverables as necessary.
  • May assist in creation of table, figure, or listing mockups under supervision of statisticians.
  • NDA submission experience is a plus
  • Supporting Data management function to program and edit, generate patient profiles, perform reconciliations, oversight of CRO in stat program
  • Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.
  • Generation of randomization schemes; unblinding of treatment assignments and appropriate handling of unblinded information.
  • Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions.
  • Must be expert of macro creation

QUALIFICATIONS:
  • A Master's or Ph.D degree in Statistics, Biostatistics, or Applied Mathematics with 5yrs+ years of experience performing statistical analyses in a regulated environment, preferably medically related including FDA, Google Cloud Platform or other relevant area, is a plus
  • (OR) Bachelor's degree in Statistics, Mathematics, or Computer Science or in a related field with minimum of 8 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer is REQUIRED
  • Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
  • Hypertension or oncology experience is a plus
  • Experience with independently setting up study from start and leading team is required
  • Experience with oversight of CRO work for outsource model is required


Why Kelly ® ?


Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®


At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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