Biostatistical Manager / Staff Biostatistician

Clinical Biostatistics

Confirmed live in the last 24 hours

Locations

Menlo Park, CA, USA

Experience Level

Entry

Junior

Mid

Senior

Expert

Desired Skills

Google Cloud Platform

Requirements

Ph.D. in Statistics, Biostatistics or equivalent with 4+ years (or MS with 6+ years ) direct industry experience will be considered at the Staff Clinical Biostatistician level
Strong knowledge of theoretical and applied statistics
Outstanding verbal, writing, and presentation skills with a strong ability to influence
Proven track record of success in supporting large-scale clinical trials as biostatistician, especially in blinded, randomized control trials
Strong track record posters/presentations and publications is desirable
Knowledge of applicable regulatory rules and guidelines, e.g. ICH, GCP and HIPPA
Proficient in R and/or SAS
Ability to work independently on multiple concurrent projects in a fast-paced environment
Strong team player with a demonstrated track record of success in the cross-functional team environment

Responsibilities

Act as lead trial Biostatistician to provide statistical support for clinical studies in the study design, analysis, interpretation, and publication of clinical studies
Co-author protocols, statistical analysis plan, study reports, presentations, and publications of clinical studies
Conduct quality and timely delivery of interim and final results, including analyses for submissions into regulatory agency (e.g. FDA)
Run statistical modeling which may lead to technical publications to contribute to the statistics society
Work closely with technical leads to provide technical support for product development and scientific discoveries
Stay abreast of industry and academic developments in Statistics and modeling techniques and apply to significant and unique issues that require exercising independent judgment and developing/adapting methodology

Desired Qualifications

Experience with machine learning techniques is a plus
Experience with FDA submission and companion diagnostics development is a plus

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

Are you passionate about collecting and analyzing clinical trial data in the uncharted territory of multi-cancer early detection and disease monitoring using cutting-edge machine learning techniques? If so, you’re in the right place! We are looking for a Biostatistics Manager/Staff Statistician who will provide statistical expertise and leadership to clinical trials! This position will partner with key internal and external stakeholders to design, analyze, and interpret clinical studies in support of GRAIL’s clinical development. This position will also provide statistical modeling expertise and conduct simulation in support of GRAIL’s clinical trial design, product development, and scientific discovery.

RESPONSIBILITIES

Act as lead trial Biostatistician to provide statistical support for clinical studies in the study design, analysis, interpretation, and publication of clinical studies
Co-author protocols, statistical analysis plan, study reports, presentations, and publications of clinical studies
Conduct quality and timely delivery of interim and final results, including analyses for submissions into regulatory agency (e.g. FDA)
Run statistical modeling which may lead to technical publications to contribute to the statistics society
Work closely with technical leads to provide technical support for product development and scientific discoveries
Stay abreast of industry and academic developments in Statistics and modeling techniques and apply to significant and unique issues that require exercising independent judgment and developing/adapting methodology

REQUIRED SKILLS

Ph.D. in Statistics, Biostatistics or equivalent with 4+ years (or MS with 6+ years ) direct industry experience will be considered at the Staff Clinical Biostatistician level
Strong knowledge of theoretical and applied statistics
Outstanding verbal, writing, and presentation skills with a strong ability to influence
Proven track record of success in supporting large-scale clinical trials as biostatistician, especially in blinded, randomized control trials
Strong track record posters/presentations and publications is desirable
Knowledge of applicable regulatory rules and guidelines, e.g. ICH, GCP and HIPPA
Proficient in R and/or SAS
Ability to work independently on multiple concurrent projects in a fast-paced environment
Strong team player with a demonstrated track record of success in the cross-functional team environment

DESIRED SKILLS

Experience with machine learning techniques is a plus
Experience with FDA submission and companion diagnostics development is a plus

The estimated, full-time, annual base pay scale for this position is $154,000 - $204,000. Actual base pay will consider skills, experience, and location.

Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.

In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.

Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.

501-1,000 employees

Website

Designs cancer screening tests

Company Overview

GRAIL's mission is to detect cancer early, when it can be cured. They are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

Benefits

Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.
Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.
Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.
Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.

Company Core Values

Grit - We are determined and resilient because patients are counting on us.
Respect - We value diversity and challenge each other respectfully.
Accountability - We own our decisions and keep our commitments.
Integrity - We adhere to our principles of humility, transparency, and rigor.
Leadership - We make each other better by making leadership everyone’s responsibility