Senior Manager of Statistical Programming

2 weeks ago

Pasadena, California, United States Arrowhead Pharmaceuticals Full time
Position Overview

Arrowhead Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization dedicated to developing innovative therapies that target challenging diseases through gene silencing techniques. Our advanced RNA interference (RNAi) technologies are at the forefront of addressing conditions that are often overlooked by traditional drug development approaches.

Role Summary

We are looking for a Senior Manager or Associate Director of Statistical Programming to enhance our dynamic biometrics team. This role is crucial in supporting clinical trials across our diverse portfolio. As a key technical authority in statistical programming, you will collaborate closely with various departments, including Clinical Development, Regulatory Affairs, Data Management, and Medical Affairs.

Key Responsibilities

  • Oversee the statistical programming team to ensure high-quality deliverables.
  • Evaluate analysis plans to ensure appropriate statistical methodologies are applied.
  • Review clinical datasets, particularly SDTM datasets, for accuracy and completeness.
  • Develop and maintain analysis databases (ADaM) for clinical studies.
  • Conduct programming for study analyses and assess study outcomes.
  • Perform ad-hoc statistical analyses and assist in manuscript preparation.
  • Communicate project requirements effectively to facilitate data cleanup and capture.
  • Contribute to the development and implementation of departmental standards and training programs.
  • Identify and manage relationships with external consultants and service providers, ensuring quality in statistical and programming outputs.

Qualifications

  • Master's degree in Biostatistics or a related discipline, with 5-7 years of relevant programming experience in the pharmaceutical or biotechnology sectors.
  • Proven management experience in statistical programming.
  • Strong proficiency in statistical software, particularly SAS, and familiarity with R Studio.
  • Exceptional verbal and written communication skills, with a focus on effective collaboration across functional teams.
  • Comprehensive understanding of the clinical development lifecycle, including regulatory submission processes.
  • Experience in managing programming services provided by CROs.
  • Familiarity with cross-functional roles within a drug development organization.

Preferred Qualifications

  • Knowledge of regulatory standards for dataset submissions, including CDISC, and the development of SDTM and ADaM specifications.

Arrowhead offers competitive compensation and a comprehensive benefits package.

All candidates must possess the necessary authorization to work in the United States.

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