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Jobs · Engineering · California

Senior Manager, Statistical Programming - Oncology Early Development

AbbVie · South San Francisco, CA · 1 wk ago
Engineering$125k–$237k/yrFull-time

About the role

The Senior Manager, Statistical Programming performs statistical programming and analysis oversight for OED (Oncology Early Development) clinical projects conducted by CROs. This individual is responsible for overseeing several compounds/indications on all statistical programming related tasks delivered by CROs. The goal is to ensure data integrity and high quality of all the analysis for oncology first in human clinical trials up through clinical proof of concept. This individual also performs hands-on programming to validate analysis datasets and TLFs delivered by CRO and support in-house studies for full set of analysis tasks. This individual may need to manage other regular or contract statistical programmers.

Responsibilities

  • Leads the statistical programming activities for one or more compounds/indications or a therapeutic area.
  • Manages a team of statistical programmers and the resource planning for their assigned projects.
  • Ensures timely deliverables, that all quality processes are followed and consistency within the projects.
  • Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards.
  • Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures.
  • Ensures consistency of ADaM data sets for individual studies and integrated data.
  • Creates documentation for regulatory filings including reviewers guides and data definition documents.
  • Leads the development of standard SAS Macros and the development of standard operating procedures.
  • Manages, mentors and creates career development plans for assigned staff.
  • Participates in the recruitment and selection of new staff.

Requirements

  • MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.
  • Minimum of 2 years experience leading a team of statistical programmers.
  • In-depth understanding of SAS programming concepts and techniques related to drug development.
  • In-depth understanding of CDISC Standards.
  • In-depth understanding of the drug development process, including experience with regulatory filings.
  • Ability to communicate clearly both oral and written.
  • Ability to effectively represent the Statistical Programming Organization in cross-functional teams.
  • Ability to accurately estimate effort required for project related programming activities.

Qualifications

  • BS in Statistics, Computer Science or a related field with 11+ years of relevant experience.

Skills

  • Strong knowledge of SAS programming.
  • In-depth understanding of CDISC Standards.
  • Experience with drug development processes and regulatory filings.
  • Excellent communication skills.
  • Ability to lead and mentor a team.
  • Ability to estimate and manage project timelines.

Benefits

  • Paid time off (vacation, holidays, sick).
  • Medical/dental/vision insurance.
  • 401(k) plan.
  • Long-term incentive programs.

Pay

$124,500 - $236,500 USD

Schedule

Hybrid

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