Biostatistics Director

6 days ago

Reston, Virginia, United States Meet Full time

Meet Meet

Biostatistics Director

We are seeking a skilled Biostatistics Director to oversee the biostatistics function for our expanding clinical development portfolio. In this strategic role, you will provide statistical insights for drug development planning, including innovative study designs and regulatory submissions. You will work collaboratively across teams to ensure the highest quality data deliverables and compliance with regulatory standards.

Key Responsibilities

  • Lead and manage the biostatistics function, aligning it with company goals and clinical objectives.
  • Foster a culture of collaboration and innovation within the biostatistics team.
  • Provide strategic input on product development, including study design and statistical methodologies.
  • Oversee the preparation and review of clinical data documentation.
  • Act as the primary contact for outsourced biostatistics activities, ensuring quality and timely deliverables.
  • Optimize biometric processes to enhance efficiency and maintain industry best practices.
  • Collaborate with cross-functional teams to ensure well-designed and statistically valid clinical trials.
  • Develop and review statistical analysis plans and reporting displays.
  • Manage statistical programming resources to ensure high-quality analysis.
  • Establish standard operating procedures and guidelines for the biostatistics team.
  • Stay current with advancements in statistics and drug development.

Qualifications

  • PhD in Statistics/Biostatistics with at least 15 years of experience in clinical development and reporting within the biotech or pharmaceutical industry.
  • Proven experience interacting with regulatory authorities and handling submission processes.
  • Strong understanding of CDISC submission requirements and biostatistical deliverables.
  • Comprehensive knowledge of statistical methodologies in clinical trial design and analysis.
  • Proficient programming skills in SAS or R are preferred.
  • Excellent interpersonal skills for effective collaboration with colleagues and external partners.
  • Willingness to travel occasionally as required.

  • Biostatistics Director

    3 weeks ago

    Reston, Virginia, United States RBW Consulting Full time

    RBW Consulting is partnering with a mid-sized Immunology biotech to fill a key leadership role. The Director of Biostatistics will oversee the biostatistics function, collaborating with cross-functional teams to deliver high-quality results.This position offers a unique opportunity to manage multiple projects, develop data review plans, and represent the...

  • Director of Biostatistics and Oncology

    2 months ago

    Reston, Virginia, United States Penfield Search Partners Ltd Full time

    Director of Oncology BiostatisticsAt Penfield Search Partners Ltd, we are seeking a highly skilled Director of Oncology Biostatistics to join our team. As a key member of our organization, you will provide scientific and statistical leadership for key molecules, working in partnership with clinical and regulatory experts to advance the delivery of crucial...

  • Senior Biostatistics Director

    2 weeks ago

    Reston, Virginia, United States Meet Full time

    We are partnering with a Metabolic Start-up Biotech to advance its therapeutic pipeline. The Head of Biostatistics will lead the statistical strategy and operations for all clinical programs, ensuring high-quality statistical methods are applied.This individual will provide strategic input into the design, execution, and interpretation of clinical trials....

  • Statistical Director

    6 days ago

    Reston, Virginia, United States Meet Full time

    Biostatistics Leadership Role(Executive Director Leveling)Position OverviewThe Director of Biostatistics provides strategic leadership and oversight of the biostatistics function to support clinical development programs. This role involves statistical input for drug development planning, including feasibility assessments, study design, statistical...

  • Clinical Operations Director

    2 months ago

    Reston, Virginia, United States Meet Full time

    Associate Director Clinical OperationsThe Associate Director of Clinical Operations plays a pivotal role in overseeing the planning, coordination, and execution of global clinical trials. This position is responsible for ensuring adherence to project milestones, managing financial aspects, and upholding quality standards in line with ICH/GCP guidelines,...

  • Director of Clinical Development

    3 weeks ago

    Reston, Virginia, United States Albion Rye Associates Full time

    Job Title: Director of Clinical DevelopmentLocation: USA, Boston Area (MA)Department: Clinical DevelopmentReports to: VP of Clinical DevelopmentCompany OverviewAlbion Rye Associates is a leading biotechnology company dedicated to transforming the lives of patients with autoimmune and inflammatory diseases. Our focus is on developing cutting-edge therapies to...

  • Senior Director Clinical Pharmacology

    6 days ago

    Reston, Virginia, United States Clinical Dynamix Full time

    Key ResponsibilitiesThe Senior Director Clinical Pharmacology at Clinical Dynamix will drive all aspects of the translational strategy, including pharmacokinetic, toxicokinetic, and pharmacodynamic assessments, biomarker development, and biodistribution studies. They will be accountable for delivering key translational milestones from candidate selection to...

  • Senior Director, Clinical Pharmacology Lead

    3 weeks ago

    Reston, Virginia, United States Clinical Dynamix Full time

    Job SummaryClinical Dynamix is seeking a highly experienced Senior Director, Clinical Pharmacology to lead our translational science efforts. This role will drive all aspects of the translational strategy, including pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and biodistribution studies.Key...