Manager, Biostatistics

South San Francisco, CA 94080

Posted: 08/08/2022 Job Category: Biometrics, Pharma / Biotech Job Number: 2566

Job Description

Manager, Biostatistics

Industry: Biopharmaceutical

Status: Full Time Employee

Location: Gaithersburg, Maryland or hybrid remote east coast

 


THE ROLE YOU WILL PLAY:

• The Manager, Biostatistics will be responsible for creating SAPs (statistical analysis plans), TLFs (Tables, Listings, Figures), and Clinical Study Report (CSR) preparation

Function as independent project statistician for multiple clinical studies

• Provide evaluations on study design and clinical trial protocols

Manage Biostatistics and statistical Programming tasks outsourced to vendors

Support the preparation of  regulatory submissions (BLAs/NDAs) with FDA and/or EU

Perform SAS Programming validation, and statistical analyses for clinical publications

 


COMPANY FEATURE AND BENEFITS:

 

  • Financially stable Biotechnology - Clinical Drug Sponsor Company
  • Ultimate goal of making meaningful changes for lives around the globe
  • Offering award-winning benefits to their employees including health benefits, salary, annual bonus, vacation and personal time-off, 401 (k)
  • Workplace environment that values each contributor as well as their families
  • Provides Leadership and Development Programs to promote employees to grow both professionally and personally

 

YOUR BACKGROUND PROFILE:

• Ph.D. or M.S. degree in Statistics/Biostatistics

3 years of industry experience in clinical drug development (sponsor or CRO)

Knowledge with regulatory submissions with FDA and/or EU

Comprehensive knowledge of clinical trial methodology, regulatory requirements, and statistical software packages

Preferred experience in adaptive design including Bayesian approach

• Excellent communication skills, both verbal and written

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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