Senior Manager, Biostatistics

San Diego, CA 92121

Posted: 07/20/2021 Job Category: Biometrics Job Number: 2437

Job Description

Senior Manager, Biostat

Industry: Pharmaceutical

Status: Full-Time Employee

Location: San Diego, CA

 

THE ROLE YOU WILL PLAY

 

  • Review or author statistical analysis sections of protocols, statistical analysis plans (SAP), clinical study reports (CSR), and regulatory documents or scientific publications.
  • Review case report forms (CRF) to ensure that protocol objectives are met and project standards are maintained.
  • Supply statistical input for regulatory submissions and in response to FDA/EMA questions.
  • Perform and report study reports of appropriate statistical analyses in collaboration with other relevant scientific disciplines to provide appropriate interpretation of data.
  • Assist in the evaluation of Contract Research Organizations (CRO), specifically the biostatistics, statistical programming, and data management areas.
  • Aid in the development of SOPs and work procedures for biostatistics, statistical programming, and data management.
  • Maintain currency with respect to FDA/EMA/ICH guidelines for statistical and clinical data analysis.

 

COMPANY PROFILE AND BENEFITS

 

  • Our client is a growing pharmaceutical company that is driven to deliver transformational medicines to patients globally, with a pipeline that includes multiple potentially first or best-in-class assets with broad clinical utility.
  • The company offers a flexible time off policy and holidays including two company-wide shut-down periods each year.
  • Known for its multicultural work environment that hosts company celebrations.
  • Exceptional compensation and benefits package.

 

BACKGROUND PROFILE

  • M.S. (with 8+ years experience)  in Statistics, Biostatistics, or Mathematics; PhD (with 5+ years experience) preferred.
  • Significant experience in full-cycle drug development/pharma required.
  • Technical knowledge of database structure and relevant statistical software such as SAS, East, and R.
  • Demonstrated experience leading change implementation using FDA/CHMP/ICH guidelines and Regulatory submission of datasets using CDISC.
  • Knowledge of pharmaceutical clinical development and ability to effectively apply technical principles, theories and concepts to clinical drug development.

 

 

 

 

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 thrive on deepening our expertise. We're energized by the life science and pharmaceutical industries, passionate about staffing, and committed to the success of our clients and candidates. That's what makes us "the name to know in recruitment."

Check out the 2020 Forbes list of Best Professional Recruiting Firms in America!  This was ABA’s 4th year in a row on this list and our 2nd year on the Best Executive Search Firms in America.

 

 

Meet Your Recruiter

Suzanne Stanford
Senior Recruiting Analyst

Suzanne joined ABA September 2020 as a Recruiting Analyst. She has a rich work history in healthcare, pharmaceutical sales, sourcing for biometrics and clinical trials, and public-sector human resources. She holds a Bachelor of Science Degree from the University of California, Davis. Suzanne upholds the client-centric business model that focuses on creating a positive experience for the client by providing exceptional service and building resilient business relationships. She firmly believes that it is not the number of calls you make in a day, rather, it is the quality of the conversation and effort put into each client/candidate to make their day easier. Suzanne gets great satisfaction sourcing for new candidates because she gets the opportunity to pair a person with a new position that will ultimately change their life and move their career forward.

A California native, Suzanne grew up in what would become Silicon Valley. She loved Santa Clara County and enjoyed the diversity of its people, the picturesque landscapes, and perfect weather. She gained valuable work experience in healthcare and pharmaceutical sales before she decided to stay home with her children. Ultimately, this choice would lead her family to move to Placer County where she then took on life as a “volunteer extraordinaire” for her local school district. She is now back in the workforce using her knowledge in healthcare and clinical data studies to pair candidates with their dream careers while assisting companies to find their ideal candidate.

Favorite Thing to do in Placer County: Hike, paddle board on Folsom Lake and enjoy the local wineries.

Favorite Quote: “I’ve learned that people will forget what you said, people will forget what you did, but people will never forget how you made them feel.”  ~ Maya Angelou

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