Senior Director, Biostatistics

1 month ago

Remote, Oregon, United States Alector Full time

We are looking for a Senior Director, Biostatistics, reporting to the VP of Biostatistics and Analytical Programming. As the Biostatistics Senior Director, you will collaborate with R&D functions to support robust and efficient study designs, develop comprehensive analysis plans, and lead the delivery of study data analysis results. You will be the expert statistical leader providing oversight and strategic feedback for the clinical programs assigned to you. The Senior Director, Biostatistics, will drive the development and implementation of statistical strategy to effectively support drug development You will directly impact company success by increasing the strength of study designs, interpretability of results, Regulatory strategy & interactions, and by implementing innovative methods to improve efficiency & quality of clinical development.

Your priorities will include:

  • As the lead compound Biostatistician for assigned projects and ensure effective, timely and compliant management and delivery of project goals and accountabilities.
  • Define the statistical strategy and ensure appropriate statistical methodologies are applied to study designs and data analyses for clinical trials.
  • Provide expert statistical input and consultancy to Phase I – IV global clinical trials, lifecycle management activities as well as translational medicine research efforts.
  • Ensure a high degree of rigor is applied to the statistical and scientific decision-making process and outcomes.
  • Collaborate with internal and external collaborators in study design, analysis, reporting, interpretation, and communication of clinical trial results.
  • Author and review critical documents such as briefing documents, protocols, SAP, top-line reports, CSR, and integrated summaries.
  • Support the project team and clinical study team including the derivation of go/no-go criteria, summary reports, and results interpretation.
  • Participate in FDA and other regulatory body interactions (IND/CTA filings, safety reporting).

We'd love to hear from you if you have:

  • Ph.D. in Statistics or related discipline with 10+ years, or MS with 15+ years of proven experience in the biotechnology or related industry, including interaction and submission experiences with both FDA and EMA.
  • Rich experience and expertise in the drug development of CNS diseases. Specifically, Alzheimer disease experience is highly desired.
  • Strong Statistical technical skills, such as innovatively applying statistical principles, theories, and concepts to clinical study designs, simulations and analyses.
  • Deep hands-on operational experiences in Biostatistics deliverables, including but not limited to study design, Statistical Analysis Plans (SAP), and producing or validating statistical outputs, etc.
  • Good project and people management skills.
  • Successful experience in managing CRO vendors for timely and quality deliveries.
  • Up to date knowledge of industry and regulatory developments in Neuroscience. Rich understanding in the industry and regulatory thinking of Alzheimer's Disease landscape is a plus.
  • Demonstrated innovative and flexible ability and mindset to work in a changing and demanding environment. Exercise good judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards.
  • Demonstrated strong leadership, project management, collaboration, communication, and organization skills.
  • Advanced programming skills in SAS, R and other relevant statistical software solutions.
  • Detailed knowledge of adaptive designs, Bayesian methodology, trial simulation, and complex modeling.
  • Innovative problem-solving capabilities, the agility to respond promptly and completely to time-critical tasks.

#LI-BL1

#LI-Remote

  • Medical/Senior Medical Director

    2 months ago

    Remote, Oregon, United States Thermo Fisher Scientific Full time

    Job DescriptionOverview:Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development...

  • Medical/Senior Medical Director

    3 weeks ago

    Remote, Oregon, United States Thermo Fisher Scientific Full time

    Job DescriptionOverview:Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development...

  • Senior Director, Data Strategy

    3 weeks ago

    Remote, Oregon, United States Bounteous Full time

    Bounteous is looking for an experienced Senior Director, Data Strategy to join our growing team. This role will be responsible for the strategic development of digital marketing data ecosystems, accomplishing data-driven analysis and activation through solution architectures integrating measurement, modeling, and martech/adtech to meet client business...

  • Senior Director, Data Strategy

    2 months ago

    Remote, Oregon, United States Bounteous Full time

    Bounteous is looking for an experienced Senior Director, Data Strategy to join our growing team. This role will be responsible for the strategic development of digital marketing data ecosystems, accomplishing data-driven analysis and activation through solution architectures integrating measurement, modeling, and martech/adtech to meet client business...

  • Senior Director, Business Development

    3 weeks ago

    Remote, Oregon, United States Bounteous Full time

    Bounteous x Accolite makes the future faster for the world's most ambitious brands. Our services span Strategy, Analytics, Digital Engineering, Cloud, Data & AI, Experience Design, and Marketing. We are guided by Co-Innovation, our proven methodology of collaborative partnership. Bounteous x Accolite brings together 5000+ employees spanning North America,...

  • Senior Director, Business Development

    3 weeks ago

    Remote, Oregon, United States Bounteous Full time

    Bounteous x Accolite makes the future faster for the world's most ambitious brands. Our services span Strategy, Analytics, Digital Engineering, Cloud, Data & AI, Experience Design, and Marketing. We are guided by Co-Innovation, our proven methodology of collaborative partnership. Bounteous x Accolite brings together 5000+ employees spanning North America,...

  • Senior Director, Business Development

    1 month ago

    Remote, Oregon, United States Bounteous Full time

    Bounteous x Accolite makes the future faster for the world's most ambitious brands. Our services span Strategy, Analytics, Digital Engineering, Cloud, Data & AI, Experience Design, and Marketing. We are guided by Co-Innovation, our proven methodology of collaborative partnership. Bounteous x Accolite brings together 5000+ employees spanning North America,...

  • Senior Director, Business Development

    1 month ago

    Remote, Oregon, United States Bounteous Full time

    Bounteous x Accolite makes the future faster for the world's most ambitious brands. Our services span Strategy, Analytics, Digital Engineering, Cloud, Data & AI, Experience Design, and Marketing. We are guided by Co-Innovation, our proven methodology of collaborative partnership. Bounteous x Accolite brings together 5000+ employees spanning North America,...

  • Senior Director, Client Service

    1 month ago

    Remote, Oregon, United States Bounteous Full time

    We are seeking a Senior Director, Client Service to join our growing Health+ Business Unit. This team member genuinely believes everyone deserves access to quality health and human services, shares our passion for innovation in healthcare, and understands the role digital plays in defining the future of healthcare access, engagement, and outcomes. The ideal...

  • Senior Director, Client Service

    3 weeks ago

    Remote, Oregon, United States Bounteous Full time

    We are seeking a Senior Director, Client Service to join our growing Health+ Business Unit. This team member genuinely believes everyone deserves access to quality health and human services, shares our passion for innovation in healthcare, and understands the role digital plays in defining the future of healthcare access, engagement, and outcomes. The ideal...

  • Senior Research Scientist- remote

    3 weeks ago

    Remote, Oregon, United States Thermo Fisher Scientific Full time

    Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...

  • HEOR/RWE Senior/Director

    3 weeks ago

    Remote, Oregon, United States Lykos Therapeutics Full time

    About Lykos Therapeutics At Lykos Therapeutics, we are committed to making an impact on people's lives. We envision a world where there are more tools available for the treatment of mental health and where conversations about mental health are destigmatized. We aspire to challenge the status quo through the development of novel therapies and therapeutic...

  • HEOR/RWE Senior/Director

    1 month ago

    Remote, Oregon, United States Lykos Therapeutics Full time

    About Lykos Therapeutics At Lykos Therapeutics, we are committed to making an impact on people's lives. We envision a world where there are more tools available for the treatment of mental health and where conversations about mental health are destigmatized. We aspire to challenge the status quo through the development of novel therapies and therapeutic...

  • Senior Director, Sustainability

    3 weeks ago

    Remote, Oregon, United States Amentum Full time

    US Citizenship is required to apply. This role is mostly remote-telework however you may be asked to come into the office now and again for meetings. Our office is in Chantilly, VA. The Senior Director of Sustainability is directly responsible for the design, implementation, and management of the company sustainability programs under the Environmental,...

  • Senior Director, Sustainability

    1 month ago

    Remote, Oregon, United States Amentum Full time

    US Citizenship is required to apply. This role is mostly remote-telework however you may be asked to come into the office now and again for meetings. Our office is in Chantilly, VA. The Senior Director of Sustainability is directly responsible for the design, implementation, and management of the company sustainability programs under the Environmental,...

  • Business Analytics Senior Advisor

    7 days ago

    Remote, Oregon, United States The Cigna Group Full time

    The job profile for this position is Business Analytics Senior Advisor, which is a Band 4 Senior Contributor Career Track Role.Excited to grow your career?We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is...

  • Business Analytics Senior Advisor

    3 weeks ago

    Remote, Oregon, United States The Cigna Group Full time

    The job profile for this position is Business Analytics Senior Advisor, which is a Band 4 Senior Contributor Career Track Role.Excited to grow your career?We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is...

  • Senior Account Director

    3 weeks ago

    Remote, Oregon, United States General Assembly Full time

    Since 2011, General Assembly (GA) has transformed tens of thousands of careers through pioneering, experiential education in today's most in-demand skills. As featured in The Economist, Wired, and The New York Times, GA offers training in web development, data, design, marketing, and more, both online and at campuses across multiple countries. Our global...

  • Senior Account Director

    1 month ago

    Remote, Oregon, United States General Assembly Full time

    Since 2011, General Assembly (GA) has transformed tens of thousands of careers through pioneering, experiential education in today's most in-demand skills. As featured in The Economist, Wired, and The New York Times, GA offers training in web development, data, design, marketing, and more, both online and at campuses across multiple countries. Our global...

  • Senior Director of Global People

    2 months ago

    Remote, Oregon, United States Core Full time

    Provide strategic oversight of all activities within Global People & Culture. Responsibilities:The Senior Director of Global People & Culture will directly oversee a team of professionals concentrated in Human Resources while building an internationally compliant, culturally relevant with focus on the development, retention and empowering of staff at CORE....