Associate Director, Biostatistics

2 days ago

South San Francisco, California, United States BioSpace, Inc. Full time
Job Summary

We are seeking an experienced Associate Director to join our team in CMC Statistics. The successful candidate will provide statistical support across a broad range of nonclinical areas, with a focus on Chemistry, Manufacture and Control (CMC). This role will involve expanding and broadening the application of Biostatistics, as well as helping the group head build the group infrastructure and mentor junior statisticians or interns.

Key Responsibilities
  • Apply statistical techniques to facilitate better decision-making and improve business operations.
  • Regularly interact with management of different levels in strategy meetings, contributing to strategic planning to ensure statistically optimized non-clinical development plans and assist in the creation of strategic objectives for regulatory filings.
  • Participate in the planning/design, conduct, analysis, and interpretation of CMC studies and regulatory submissions, as well as establishing departmental and nonclinical SOPs and guidelines.
  • Develop statistical tools to streamline process development, QC testing, and troubleshooting, collaborating with colleagues from other departments to ensure compliance with regulations and help implement regulatory initiatives such as Quality by Design and process validation.
  • Collaborate with external colleagues on consortia and other research projects relevant to nonclinical topics, prepare statistical courses and provide training to scientists, and mentor junior staff, proactively helping with both their technical and career development.
  • Develop and deliver statistical and scientific publications, and present internally and externally, collaborating with other statisticians in improving and sharing statistical approaches.
  • Maintain and expand expertise in various computing tools to leverage internal and external data sets to drive decisions, examples of such tools include R, Spotfire, SAS, etc.
Qualifications
  • MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field.
  • High degree of technical competence and excellent communication skills, both oral and written.
  • Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others.
  • Able to manage project timeline and quality of deliverables.
  • Able to build strong relationship with peers and cross-functional partners to achieve higher performance.
  • Have strong leadership skills and experience in working/managing cross-cultural or oversea teams.
  • Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.
  • (SSG) Experience leading safety-related projects (eg, ISS, benefit-risk assessment, signal detection).
  • (GMA Stat) Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming.

  • Associate Director, Biostatistics

    1 day ago

    South San Francisco, California, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking an experienced Associate Director, Statistics to join our team at BioSpace, Inc. This role will provide statistical support across a broad range of nonclinical areas with a focus on Chemistry, Manufacture and Control (CMC), expanding and broadening the application of Biostatistics.Key ResponsibilitiesApply statistical techniques to...

  • Executive Director of Biostatistics

    3 days ago

    South San Francisco, California, United States Meet Full time

    Executive Director Biostatistics Job DescriptionJob Summary:The Executive Director of Biostatistics will provide strategic leadership and oversight of the biostatistics function to support clinical development programs. This role offers strategic statistical input for drug development planning, including feasibility assessments, study design, statistical...

  • Senior Director of Biostatistics

    2 weeks ago

    San Diego, California, United States Barrington James Full time

    Senior Director, Biostatistics - Biotech (SAN DIEGO) - ON-SITE / HYBRIDWe are collaborating with a leading Biotech company to find a Senior Director, Biostatistics.The company is working on treatments for rare diseases, with a pipeline including 4 Phase II studies and a pivotal Phase III study.Key Requirements:Master's or Ph.D. in Statistics or...

  • Senior Director Biostatistics

    2 weeks ago

    San Diego, California, United States Barrington James Full time

    Senior Director, Biostatistics - BiotechBarrington James is working closely with a specialist Biotech company to hire a Senior Director, Biostatistics.The company is focused on finding treatments for unmet rare diseases and has a pipeline that includes 4 Phase II studies and a pivotal Phase III study to move forward with submission.Ideal Candidate will...

  • Senior Director of Biostatistics

    2 weeks ago

    San Bernardino, California, United States Edwards Lifesciences Full time

    Senior Director, BiostatisticsEdwards Lifesciences is seeking a highly skilled Senior Director, Biostatistics to lead our Transcatheter Heart Valve business unit's biostatistics efforts. As a key member of our team, you will be responsible for managing biostatistics teams and activities, providing strategic clinical and statistical leadership, and...

  • Director, Biostatistics and Data Science

    3 weeks ago

    San Francisco, California, United States Pfizer, S.A. de C.V Full time

    About the RolePfizer, S.A. de C.V is seeking a highly skilled and experienced Director, Biostatistics and Data Science to join our team. As a key member of our Oncology Biometrics department, you will play a critical role in the design, analysis, and interpretation of clinical trials.Key ResponsibilitiesStudy Statistician and Program LeadProvide statistical...

  • Senior Director of Biostatistics

    1 week ago

    San Bernardino, California, United States Edwards Lifesciences Full time

    Senior Director, BiostatisticsEdwards Lifesciences is seeking a highly skilled Senior Director, Biostatistics to join our team. As a key member of our Transcatheter Heart Valve business unit, you will be responsible for leading biostatistics teams and activities, providing overall management of statistics globally, and driving business growth through...

  • Director of Biostatistics and Programming

    2 weeks ago

    San Francisco, California, United States BioTalent Canada Full time

    About the RoleWe are seeking a highly skilled and experienced Director of Biostatistics and Programming to join our Clinical Development team at Zymeworks. As a key member of our leadership team, you will be responsible for developing and implementing strategic plans to drive the growth and success of our biometrics and statistical programming...

  • Senior Biostatistics and Clinical Operations Director

    3 weeks ago

    San Bernardino, California, United States Edwards Lifesciences Full time

    About the RoleEdwards Lifesciences is seeking a highly skilled Senior Director, Biostatistics and Clinical Leadership to join our team. As a key member of our organization, you will be responsible for leading biostatistics teams and activities, providing overall management of statistics globally, and driving business growth through data-driven insights.Key...

  • Senior Vice President, Biostatistics and Analytics

    3 weeks ago

    South San Francisco, California, United States Annexon Bioscience Full time

    About the RoleWe are seeking a highly experienced and accomplished Executive Director, Biometrics and Data Science to lead our Biometrics team at Annexon Biosciences. As a key member of our leadership team, you will be responsible for providing strategic direction and operational oversight for all aspects of biostatistics, statistical programming, modeling...

  • Director of Statistical Programming

    3 days ago

    South San Francisco, California, United States Meet Full time

    {"title": "Director of Statistical Programming", "content": "Job SummaryThe Director of Statistical Programming will provide strategic oversight, planning, and execution of the statistical programming function to support an expanding portfolio of clinical development programs. This role will collaborate with key stakeholders across Biometrics, Data...

  • Clinical Quality Assurance Director

    4 weeks ago

    South San Francisco, California, United States GQR Full time

    Position Title: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Status: Full-time direct hire; Hybrid role with 3 days onsiteThe Director of Clinical Quality Assurance (CQA) is a pivotal role that demands active engagement in ensuring that clinical trials comply with relevant GCP regulations (such as FDA, international, and...

  • Senior Biostatistician

    5 days ago

    San Francisco, California, United States Daiichi Sankyo, Inc. Full time

    Job Title: Associate Director, BiostatisticsAbout Daiichi Sankyo, Inc.Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to improving the lives of patients worldwide. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to providing novel therapies in oncology and other research areas.Job...

  • Director of Biological Data Science and Analytics

    3 weeks ago

    San Francisco, California, United States Celebree School of Elkridge Full time

    Celebree School of Elkridge is seeking a highly motivated Director of Biological Data Science and Analytics to lead a team of computational biologists, bioinformaticians, and data engineers. The role involves overseeing strategic planning for bioinformatic analysis pipelines and collaborating with multidisciplinary teams on project designs.Key...

  • Senior Director of Biometrics and Data Science

    3 weeks ago

    San Diego, California, United States Luminary Group Full time

    Job DescriptionLuminary Group is seeking a highly skilled and experienced Senior Biometrics Director to lead our biostatistics and data management functions. As a Biometrics leader, you will play a key role in overseeing the design, analysis, and reporting of clinical trial data, ensuring high quality and regulatory compliance.Key Responsibilities:Team...

  • Associate Director/Director, Head of Discovery Analytical Chemistry

    1 day ago

    South San Francisco, California, United States IDEAYA Biosciences Full time

    Job Title: Associate Director/Director, Head of Discovery Analytical ChemistryIDEAYA Biosciences is a leading precision medicine oncology company committed to the discovery and development of targeted therapeutics. We are seeking an experienced Associate Director/Director, Head of Discovery Analytical Chemistry to join our multidisciplinary team based in...

  • Associate Director, Quality Control, Reference Standards

    4 hours ago

    San Carlos, California, United States BioSpace, Inc. Full time

    Job SummaryVaxcyte is seeking an experienced Associate Director to lead the quality control team in managing reference standards and critical reagents. The successful candidate will be responsible for developing and implementing policies, procedures, and strategies for global reference standard and critical reagent management systems.Key...

  • Professional Researcher: Assistant, Associate, or Full

    1 week ago

    San Francisco, California, United States UCSF Benioff Children's Hospitals Full time

    Job OpportunityWe are seeking a highly qualified Professional Researcher to join our team at the University of California, San Francisco (UCSF). This is an exciting opportunity to contribute to innovative research in the field of epidemiology and biostatistics.About the PositionThe Professional Researcher will work closely with our team to design, conduct,...

  • Pharmacometrics Director

    2 weeks ago

    San Francisco, California, United States Vir Biotechnology, Inc. Full time

    {"h1": "Pharmacometrics Director Job Opportunity at Vir Biotechnology, Inc.", "p": "We are seeking a highly skilled Pharmacometrics Director to lead our pharmacometrics strategy across therapeutic areas and programs, from early clinical development to market application and commercialization. The successful candidate will join the Clinical Pharmacology...

  • Ladder Rank Faculty Position

    2 weeks ago

    San Francisco, California, United States University of California , San Francisco Full time

    Job OpportunityWe are seeking a highly qualified individual to join our team as a Ladder Rank Faculty Position in the Department of Epidemiology and Biostatistics at the University of California, San Francisco.The successful candidate will have a strong background in quantitative epidemiology, including modern causal inference, and a proven track record of...