Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Their research and close collaboration with the ALS community ultimately resulted in our first commercial product, which is now approved in the U.S. and conditionally approved in Canada.
At Amylyx, we’re bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable in the fight against neurodegenerative diseases like, ALS, Alzheimer’s disease, Wolfram Syndrome and others.
Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences—in all the best ways.
Recent milestones include:
The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022
Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022
AMX0035 is currently under review with the European Medicines Agency
350 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands — and growing strong!
THE ROLE
The Head, Early Development Biostatistics will be responsible for driving the statistical input to the design, analysis, reporting and interpretation of clinical studies from early to late phases. This highly interactive role will work closely with Clinical, Regulatory, Statistical Programming, Data Management, and other functional area experts. You will build and maintain effective strategic working relationships with internal and external partners to meet business needs. This person will also be a key influence in clinical development plans, as well as regulatory and commercial strategies to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs.
RESPONSIBILITIES
Act as statistical strategic lead and provide expert statistical input to drug development including development plans, innovative or adaptive study designs, and cross-study analyses including basic and complex statistical methodology implementation, data interpretations, regulatory submissions.
Develop individual protocols and data analysis plans and determine appropriate statistical methodology for analysis.
Ensure that data analysis and results interpretation from clinical trials meet objectives of the study protocol and are scientifically sound.
Lead projects by managing statistical tasks, resources, timelines and budgets.
Provide mentorship for junior statisticians and execute critical statistic deliverables and milestones in collaboration with other functions.
Lead presentations of statistical data and results of clinical trials to Company Management, regulatory agencies, or individual investigators.
Participate and collaborate in database design meetings to ensure that the data evaluated is in high quality and satisfies analysis requirements.
Exercise statistical oversight for studies outsourced to external partners while ensuring high quality and consistency with company and industry standards.
Prepare and deliver responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
Plan and ensure the accuracy of Statistical Review Aids submitted to regulatory agencies.
Collaborate with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
REQUIREMENTS
PhD in statistics/biostatistics with 10+ years relevant work experience, or a Master’s degree with 12+ years relevant work experience.
Expert knowledge of statistical methodologies such as longitudinal data analysis, Bayesian modeling and adaptive designs.
Working knowledge of statistical and data processing software e.g., SAS and/or R.
Good understanding of worldwide regulatory requirements and clinical trial expertise from early phase to late phase.
Strong oral and written communication skills. Able to function effectively in a team environment.
Advanced knowledge of the pharmaceutical industry, and overall drug development process.
PREFERRED QUALIFICATIONS
Prior experience in first-in-human trials and early drug development
Strong project management skills.
An understanding of biology of disease and drug discovery.
People management experience.
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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
Originally posted on Himalayas
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Director Of Data Analytics, Head of Business Development
