AbbVie

Associate Director, Biostatistics

Employer
AbbVie
Location
Irvine, California
Posted
Mar 10, 2021
Ref
2101946
Required Education
Doctorate/PHD/MD
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Introduction

The position can independently lead one or more projects ensuring the proper design, analysis, and presentation of clinical studies while adhering to timelines and departmental quality-control standards. This position interacts with domestic and foreign regulatory agencies for Allergan R&D projects.  The position also monitors budgetary and resource needs, and evaluates, hires, and manages CROs and/or contract biostatisticians.

The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.

 

Responsibilities

  • Independently lead one or more projects ensuring the proper design, analysis, and presentation of clinical studies while adhering to timelines and departmental quality-control standards. This position interacts with domestic and foreign regulatory agencies for Allergan R&D projects.  
  • Monitors budgetary and resource needs, and evaluates, hires, and manages CROs and/or contract biostatisticians.
  • Assist statistical science process development as needed to improve the efficiency and standardization
  • Represent Statistical Science and Programming on cross-functional project teams. 

Qualifications
  • Masters or PhD (preferred) in Statistics, Biostatistics, or related field required
  • PhD-level candidate with at least 7 years of experience in pharmaceutical statistics or MS-level candidate with at least 9 years of experience required in pharmaceutical statistics
  • Experience managing a whole project; study-level statistician for reasonable complex project from study design to CSR
  • 1-2 NDA regulatory experience required 

Note: While this job description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add or remove duties from a particular job and to assign other duties as necessary and at any time.


Significant Work Activities
N/A
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.