Senior Manager, Biostatistical Programming

Location: Remote

Summary

The Senior Manager of Biostatistical Programming at RayzeBio will be accountable for development of clinical study related deliverables and timelines, oversee study vendors’ programming deliverables, and support company internal requests.

Job Responsibilities

Essential duties and responsibilities include the following.  Other duties may be assigned.

  • Oversee vendors’ activities, and review vendors’ deliverables to ensure quality.
  • Participate in reviewing, analyzing, and reporting clinical trial data and generating outputs to support DSUR/IBs, publications, FDA meeting briefing documents, and other internal ad-hoc requests.
  • Collaborate with cross-functional teams to review critical study documents and perform data reviews for ongoing studies.
  • Oversee CDISC data package development for clinical studies to support CSRs and future regulatory submissions.
  • Create SAS macros/applications to streamline processes and enhance efficiency.
  • Create/QC SDTM/ADaM data specifications, create/QC CDISC datasets and provide/QC outputs based on protocols/SAP.

Education and Experience

  • A bachelor’s degree required in statistics, mathematics or equivalent with at least 10 years’ experience in pharmaceutical industry; or a master’s degree in statistics or computer science with at least 7 years’ programming experience is preferred.
  • Oncology therapeutic area experience required.
  • Proven ability to manage CRO relationships and oversee programmed deliverables.
  • Advanced skills in SAS programming and statistical reporting.
  • Knowledge with FDA and ICH regulations and guidelines, and clinical trial methodologies.
  • Good written and verbal communication skills.
  • Be able to work productively in a fast-paced collaborative environment.
  • Willing to travel approximately 10% of the time.  Evening and weekend work will be involved.

Physical demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.

Work Environment

The noise level in the work environment is usually moderate.

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