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Senior Manager of Statistical Programming

2 months 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 complex diseases through gene silencing techniques. Our commitment to advancing RNA interference (RNAi) technologies positions us at the forefront of addressing genetic disorders by effectively silencing the genes responsible for these conditions.

Role Summary

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

Key Responsibilities

  • Oversee and lead the statistical programming team.
  • Evaluate analysis plans to ensure the application of suitable methodologies.
  • Review clinical datasets in accordance with SDTM standards.
  • Develop and maintain analysis databases (ADaM).
  • Conduct programming for study analyses and critically assess study outcomes.
  • Perform ad-hoc and exploratory statistical analyses and assist in manuscript preparation.
  • Facilitate communication regarding project requirements for data integrity and capture.
  • Contribute to the development and implementation of departmental standards and training initiatives.
  • Assist in the selection and management of external consultants and service providers, ensuring the quality of 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.
  • Demonstrated management experience in statistical programming.
  • Expertise in statistical software, particularly SAS, and familiarity with R Studio.
  • Strong verbal and written communication skills, with a proven ability to collaborate effectively across functional teams.
  • Comprehensive understanding of the clinical development lifecycle, including regulatory submission processes.
  • Experience in managing programming services provided by contract research organizations (CROs).
  • Familiarity with the roles and functions of various departments within a drug development company.

Preferred Qualifications

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

Arrowhead offers competitive compensation and a comprehensive benefits package.

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