Director Biostatistics

3 weeks ago

Waltham, United States Upstream Bio Full time

Position Summary:

The Director, Biostatistics will provide strategic input and operational leadership for all biostatistical activities related to our clinical trials. Collaborating closely with cross-functional teams, this role requires a seasoned professional with deep expertise in biostatistics, clinical trials, and regulatory requirements. The Director will ensure the integrity, quality, and compliance of statistical analyses, contributing to the successful development and approval of new therapies.


Key Responsibilities:

  • Collaborate with cross-functional teams, to align biostatistical strategies with clinical development goals.
  • Be accountable for statistical aspect of the design and analysis of clinical trials, including the development of statistical analysis plans (SAPs) and the execution of statistical analyses.
  • Oversee vendor performance, ensuring deliverables meet quality and compliance standards. Ensure the accurate and timely delivery of high-quality statistical outputs, including tables, listings, figures, and clinical and regulatory documents including CSRs, INDs, NDAs/BLAs.
  • Conduct statistical analyses to support clinical trial design, result exploration, and publications.
  • Represent Biostatistics at relevant governance/review forums and in Regulatory correspondence where appropriate.
  • Communicate effectively across all functional areas so that deliverables and interdependencies are clear.

Qualifications:

  • PhD or Master’s degree in Biostatistics, Statistics, or a related field.
  • Minimum of 10 years of experience in biostatistics within the biotech or pharmaceutical industry.
  • Proven expertise in the design and analysis of clinical trials, including phase I-IV studies.
  • Strong knowledge of regulatory requirements (e.g., FDA, EMA, ICH-GCP) and industry best practices.
  • Experience with statistical software (e.g., SAS, R) and data management systems.
  • Excellent leadership, communication, and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Ability to work collaboratively in a fast-paced, dynamic environment.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at upstreambio.com.

  • Director of Biostatistics

    4 weeks ago

    Waltham, Massachusetts, United States Upstream Bio Full time

    Job Title: Director of BiostatisticsUpstream Bio is a pioneering biotech company dedicated to developing innovative therapeutics for inflammation. We are a dynamic organization with a strong financial foundation, having secured $400M in funding from reputable investors. Our clinical-stage asset, verekitug, is poised for Phase 2 studies in 2024, targeting...

  • Director of Biostatistics

    3 weeks ago

    Waltham, Massachusetts, United States Upstream Bio Full time

    Director Biostatistics Job DescriptionAt Upstream Bio, we are seeking a highly skilled Director of Biostatistics to join our team. As a key member of our organization, you will play a critical role in the design and analysis of our clinical trials.Key Responsibilities:Collaborate with cross-functional teams to develop biostatistical strategies that align...

  • Director Biostatistics

    1 month ago

    Waltham, United States Upstream Bio Full time

    Position Summary: Upstream Bio is developing innovative therapeutics to treat inflammation. We are a nimble company with solid financial backing having raised $400M from high-quality investors. We have a clinical stage asset, verekitug, focusing on two Phase 2 studies in 2024 in asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plans to expand...

  • Director Biostatistics

    2 weeks ago

    waltham, United States Upstream Bio Full time

    Position Summary: The Director, Biostatistics will provide strategic input and operational leadership for all biostatistical activities related to our clinical trials. Collaborating closely with cross-functional teams, this role requires a seasoned professional with deep expertise in biostatistics, clinical trials, and regulatory requirements. The Director...

  • Director Biostatistics

    2 weeks ago

    Waltham, United States Upstream Bio Full time

    Position Summary: The Director, Biostatistics will provide strategic input and operational leadership for all biostatistical activities related to our clinical trials. Collaborating closely with cross-functional teams, this role requires a seasoned professional with deep expertise in biostatistics, clinical trials, and regulatory requirements. The Director...

  • Senior Biostatistics Director

    2 weeks ago

    Waltham, Massachusetts, United States Upstream Bio Full time

    Job Title: Director BiostatisticsAt Upstream Bio, we are seeking a highly experienced and skilled Director of Biostatistics to lead our biostatistical activities related to clinical trials. This role requires a seasoned professional with deep expertise in biostatistics, clinical trials, and regulatory requirements.Key Responsibilities:Collaborate with...

  • Director of Business Development for Life Sciences

    2 weeks ago

    Waltham, Massachusetts, United States Softworld, a Kelly Company Full time

    About Softworld, a Kelly CompanyWe are a professional services company catering to the life sciences industry, specializing in clinical data analytics solutions and functional outsourcing services.Our team is proficient in various areas, including Clinical Data Management, Regulatory Submissions, Biostatistics, Statistical Programming, Data Analytics, and...

  • Director of Business Development for Life Sciences

    2 weeks ago

    Waltham, Massachusetts, United States Softworld, a Kelly Company Full time

    About Softworld, a Kelly CompanyWe are a professional services company catering to the life sciences industry, specializing in clinical data analytics solutions and functional outsourcing services.Our team is proficient in various areas, including Clinical Data Management, Regulatory Submissions, Biostatistics, Statistical Programming, Data Analytics, and...

  • Senior/Executive Medical Director, Sleep Medicine

    5 months ago

    Waltham, United States Alkermes Full time

    The Senior/Executive Medical Director for Sleep Medicine is a highly visible and business-critical role that is part of the Medical Strategy team within Alkermes Medical Affairs. This role leads medical affairs efforts within our sleep medicine program, inclusive of our orexin agonist in clinical development and future compounds for the treatment of...

  • Director of Business Development for Life Sciences

    6 days ago

    Waltham, Massachusetts, United States Softworld Full time

    About Vita Global SciencesSoftworlds Vita Global Sciences is a professional services company catering to the life sciences industry. We specialize in offering clinical data analytics solutions and functional outsourcing services.Our team is proficient in various areas, including Clinical Data Management, Regulatory Submissions, Biostatistics, Statistical...

  • Data Analyst

    2 months ago

    Waltham, Massachusetts, United States LLX Solutions Full time

    Job Title: StatisticianWe are seeking a highly skilled Biostatistician to join our team at LLX Solutions.Position Overview:The Biostatistician will be responsible for reviewing protocols and case report forms, performing sample size calculations, writing Statistical Analysis Plans, developing and producing interim and final reports.This position will also...

  • Data Analyst

    1 month ago

    Waltham, Massachusetts, United States LLX Solutions Full time

    Job Title: Statistician IWe are seeking a highly skilled Biostatistician to join our team at LLX Solutions. Position Overview:\tThe Biostatistician will be responsible for reviewing protocols and case report forms, performing sample size calculations, writing Statistical Analysis Plans, and developing and producing interim and final reports.\tAdditionally,...

  • Data Analyst

    2 weeks ago

    Waltham, Massachusetts, United States LLX Solutions Full time

    Job Title: BiostatisticianWe are seeking a highly skilled Biostatistician to join our team at LLX Solutions. Position Overview:The Biostatistician will be responsible for reviewing protocols and case report forms, performing sample size calculations, writing Statistical Analysis Plans, and developing and producing interim and final reports.This position will...

  • Statistician

    5 months ago

    Waltham, United States LLX Solutions Full time $82,000 - $96,000

    Job Title: Statistician IWe have an immediate opening for an entry-level Biostatistician. Position Overview:The Biostatistician may review protocols and case report forms, perform sample size calculations, write Statistical Analysis Plans, develop and produce interim and final reports.Additionally, this position will support Project Directors in the...