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Gates Medical Research Institute

Job Title: Clinical Biostatistics Leader

Job Number: 28051

Location: Cambridge, MA

Job Description

The Head of Clinical Biostatistics will report to and serve as a thought partner to the Head of Development/Chief Medical Officer. In this role you work collaboratively with other Development team members to guide our clinical development strategies. This role will be responsible for overseeing all aspects of clinical development across small molecules, biologics, vaccines, and diagnostics, while also providing statistical support to preclinical groups. In particular, the Clinical Biostatistics Leader will be charged with developing and applying cutting-edge statistical methods to accelerate clinical development, including routine use of Bayesian approaches and novel adaptive trial designs through the application of modeling and simulation approaches to clinical trial design.

Responsibilities

Working closely with clinical assay development leads and other Quantitative Sciences team members, the Head of Clinical Biostatistics will deploy novel and rigorous approaches to the use of biomarkers and bioinformatics tools that will expand the use of surrogate endpoints in clinical trials.   You will also provide statistical input into the design of nonclinical pharmacology, toxicology and other preclinical studies.  In response to our growing portfolio, the Head of Clinical Biostatistics will also have the opportunity to manage and grow other statisticians as well as both our Data Management and Programming capabilities though a combination of hiring and effective use of consultants and outsourced partners.  You will play a key role in oversite of our data integrity, CROs and other  partners which include global academic, nonprofit and industry institutions.
 
At the Gates MRI, we are a team of ‘strategic doers’ in an environment where each of us is expected to bring innovative strategies combined with a ‘roll up your sleeves’ mentality as we seek to bring treatments to the world’s most underserved populations.

Required Skills

  • PhD in Biostatistics, Mathematics or a related field
  • 5-10 years of experience in the pharmaceutical or biotech industries
  • Strong methodological technical and analytical expertise, with leadership experience in both early and late development contributing to governance milestones, strategy, health authority interactions, protocols and submissions
  • Proven track record of effective leadership experience including managing reports, teams, taskforces or initiatives
  • Proven knowledge and expertise in statistics, statistical programming and data management, and its applications to clinical trials
  • Knowledge of FDA, EMA, ICH guidelines and regulations related to clinical trials, statistics and data handling
  • Prior registration and IND/NDA/BLA experience
  • Sound knowledge of clinical database management, statistical programming languages (including SAS), software.
  • Excellent communication and presentation skills; a team player, with ability to work successfully across functions
  • Experience with translational data analysis, managing biostatistics, statistical programming and data management preferred
  • Experience with outsourcing biometrics activities, and in overseeing services provided by CROs and contractors preferred.

 

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