Associate Director, Biostatistics

South San Francisco, CA 94080

Posted: 11/20/2020 Job Category: Pharma / Biotech Job Number: 2264

Job Description

Associate Director, Biostatistics
Industry:
Biopharmaceutical
Status: Full-time Employee
Location: Chicago – Open to Remote
 

THE ROLE YOU WILL PLAY:

  • The Associate Director, Biostatistics will be responsible for developing and implementing SAPs (statistical analysis plans), Quality Control (QC ) on Tables, Listings, Figures (TFLs), and Clinical Study Report (CSR) preparation
  • Review and execute regulatory submissions (BLA or NDA) with FDA and/or EU
  • Conduct assessments on study design and clinical trial protocols to provide improvements
  • Author adaptive designs, including Bayesian Approach
  • Spearhead the clinical trial for an investigational drug through to FDA approval

 

COMPANY FEATURE AND BENEFITS:

  • Our client focuses on Rare and Rheumatic diseases with the ultimate goal of making meaningful changes for lives around the globe
  • While maintaining strong financial stability, our client has displayed sustainable growth that provides significant opportunities for career advancement
  • Offering award-winning benefits to their employees including health benefits, salary, annual bonus, vacation and personal time-off, 401 (k); our client has created a workplace environment that values each contributor as well as their families
  • A growing team of innovative thinkers who will work with a hands-on approach to bring the clinical trial process in house and tackle complicated trials
  • Our client provides Leadership and Development Programs to promote employees to grow both professionally and personally

 

YOUR BACKGROUND PROFILE:

  • Ph.D. in Statistics/Biostatistics
  • > 10 years of pharmaceutical experience specifically in clinical drug development
  • Experience handling regulatory submissions with FDA and/or EU
  • Skillful at adaptive design including Bayesian approach

 

ABOUT ABA SEARCH:

At ABA Search, we value professionalism, honesty, and hard work. We’re positive, innovative thinkers, and we use creativity to turn challenges into opportunities. We love to learn, and we continuously seek new ways to deepen our expertise. We’re energized by the biopharmaceutical and legal industry, passionate about staffing, and committed to the success of our clients and candidates. That's what makes us “the name to know in recruitment.”

 

For the past 2 years, ABA has been ranked as one of the Best Professional Recruiting Firms in America

Meet Your Recruiter

Denise Levine
Director, Executive Search - Biometrics

Denise joined ABA in 2019, as a Director of Executive Search. She has been working as a Recruiter for the past 16 years, 10 of which have been supporting the Biotechnology and Pharmaceutical industries, specifically in the areas of biometrics and clinical trials. She holds a Bachelor of Arts degree in Psychology from Emmanuel College in Boston, MA. Denise takes pride in developing long-term relationships and is particularly excited about getting to know clients and candidates beyond the job description and the resume. She is passionate about connecting top talent with the right opportunity. 

Born and raised in the San Francisco Bay Area, Denise played soccer throughout her youth and also in college. She's currently the Assistant Coach to her son's soccer team. Denise lives in Placer County where she enjoys family time with her husband, two boys, and their chocolate lab, Suzy. She spends her weekends on house projects, gardening, crafting, coaching her son’s soccer team, exploring, spending time with friends and family, and camping.

Favorite things to do in Placer County: Exploring all of the fun activities Placer County has to offer, lake days, and wine tasting

Favorite Quote: "Keep your face always toward the sunshine and shadows will fall behind you." – Walt Whitman

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