Penumbra

Penumbra

Manager, Statistical Programming

Your Remote US Home Office

Sponsorship not specified$158k-$227kDetected 13 days ago
PythonGitData AnalysisData ScienceStatisticsForecastingSAPPerformance ManagementIntellectual PropertyClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesSASResearchLeadershipCommunicationCollaborationProblem SolvingOrganizational Skills

About the role

  • This individual is responsible for ensuring the quality, integrity, and timely delivery of programming deliverables supporting clinical studies, publications, and regulatory submissions.
  • Participate in the development of CRFs, edit check specifications, and data validation reports. • Participate in the review of SAP and Shells.
  • Working Conditions • General office environment. • Willingness and ability to work on site.

Requirements

  • Willingness and ability to work on site.

Nice to have

  • Master's or higher degree preferred in Statistics, Data Science, Computer Science, Mathematics, or related field with 6+ years of relevant experience.
  • 1+ years of experience in a supervisory role desired.
  • Strong leadership and interpersonal skills are highly desired.
  • Regulatory filing experience preferred.
  • Experience with clinical trials, including familiarity with expectations of regulatory agencies (e.g., FDA, PDMA) preferred.
  • Able to effectively represent the clinical statistical programming function in cross functional teams.
  • Able to accurately estimate the effort required for project related programming activities.
  • High degree of technical competence and communication ability, both oral and written.

Skills

  • Oversee team effort related to derive data sets and programs, and analysis data set specifications. *
  • Ensure consistency analysis of data sets following appropriate standards for clinical studies. Ensure consistency within a therapeutic area.
  • Monitor and quantify efficiency, accuracy, and timeliness of the group.
  • Ensure efficient programming techniques are utilized by programmers.
  • Ensure other members of the department to follow the QMS, regulations, standards, and procedures. *

Compensation

  • $158,000 - $227,000 This is the pay range for a mid-cost labor market.
  • If hired in another region, there will be a difference in pay range.
  • We offer a competitive compensation package plus a benefits and equity program, when applicable.
  • Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

Benefits

  • A collaborative teamwork environment where learning is constant, and performance is rewarded.
  • Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.
  • Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need.

Equal opportunity

  • For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.
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This listing is sourced directly from Penumbra's careers page and normalized into a canonical job model.