Current jobs related to VP, Biometrics/ Biostatistics - San Diego - Kumquat Biosciences Inc

  • Senior Director of Biometrics

    2 months ago

    San Diego, United States Luminary Group Full time

    Job DescriptionJob DescriptionLuminary Group is seeking a talented and experienced Senior Biometrics Director to join our client. As a Biometrics leader, you will play a key role in leading and managing the biostatistics and data management functions within the company. You will be responsible for overseeing the design, analysis, and reporting of clinical...

  • Executive Director Biostatistics

    1 day ago

    South San Francisco, United States Meet Full time

    Executive Director, Biostatistics - Head of Biostatistics(Hybrid 3 days weekly in South San Francisco, CA) Position OverviewThe Executive Director of Biostatistics will provide strategic leadership, oversight, and execution of the biostatistics function to support a growing portfolio of clinical development programs. This role offers strategic statistical...

  • Senior Director of Biometrics and Data Science

    2 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...

  • Vice President, Biometrics

    2 weeks ago

    san diego, United States Barrington James Full time

    VP Biometrics - San Diego - PharmaWe are working closely with a growing Pharmaceutical company seeking a VP Biometrics to join on a permanent basis.Ideal candidate will have strong FDA and regulatory experience, coupled with late Phase Oncology.This is a position reporting into C-suite with great visibility. Growing company and you will have the chance to...

  • Vice President, Biometrics

    2 weeks ago

    San Diego, United States Barrington James Full time

    VP Biometrics - San Diego - PharmaWe are working closely with a growing Pharmaceutical company seeking a VP Biometrics to join on a permanent basis.Ideal candidate will have strong FDA and regulatory experience, coupled with late Phase Oncology.This is a position reporting into C-suite with great visibility. Growing company and you will have the chance to...

  • Vice President, Biometrics

    2 weeks ago

    San Diego, United States Barrington James Full time

    VP Biometrics - San Diego - PharmaWe are working closely with a growing Pharmaceutical company seeking a VP Biometrics to join on a permanent basis.Ideal candidate will have strong FDA and regulatory experience, coupled with late Phase Oncology.This is a position reporting into C-suite with great visibility. Growing company and you will have the chance to...

  • Vice President, Biometrics

    2 weeks ago

    san diego, United States Barrington James Full time

    VP Biometrics - San Diego - PharmaWe are working closely with a growing Pharmaceutical company seeking a VP Biometrics to join on a permanent basis.Ideal candidate will have strong FDA and regulatory experience, coupled with late Phase Oncology.This is a position reporting into C-suite with great visibility. Growing company and you will have the chance to...

  • Director of Biostatistics and Programming

    1 week 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...

  • Executive Director of Biostatistics

    2 hours 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 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...

  • Associate Director, Biostatistics

    4 weeks ago

    South San Francisco, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients.    We are seeking an Associate Director of...

  • Senior Director of Biometrics

    1 week ago

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

    About UsNkarta, Inc. is a pioneering biotechnology company headquartered in South San Francisco, dedicated to revolutionizing cell therapy for patients worldwide. Our mission is to bring cutting-edge, off-the-shelf natural killer (NK) cell therapies to the community setting, expanding access and improving patient outcomes.Job SummaryWe are seeking an...

  • Director, Biostatistics and Data Science

    2 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...

  • Director Statistical Programming

    1 day ago

    South San Francisco, United States Meet Full time

    Director, Statistical Programming - Head of Statistical Programming(Hybrid 3 days per week in South San Francisco, CA)Position OverviewThe 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...

  • Statistical Programming Lead

    2 weeks ago

    San Diego, California, United States Arrowhead Pharmaceuticals Full time

    About the RoleArrowhead Pharmaceuticals is seeking a highly skilled Statistical Programming Lead to join our rapidly growing biometrics team. As an internal expert in statistical programming, you will provide technical leadership and statistical programming input to collaborate with other functional teams at Arrowhead, including Clinical Development and...

  • VP, Regulatory Affairs Strategist

    3 weeks ago

    San Francisco, California, United States Tbwa ChiatDay Inc Full time

    About the RoleWe are seeking a highly experienced and skilled VP, Regulatory Affairs Strategist to join our team at insitro. As a key member of our leadership team, you will be responsible for developing and implementing global regulatory strategies to support the development of multiple therapeutics and diagnostics.Key ResponsibilitiesRegulatory Strategy...

  • VP, Regulatory Affairs Strategist

    3 weeks ago

    San Francisco, California, United States Tbwa ChiatDay Inc Full time

    About the RoleWe are seeking a highly experienced and skilled VP, Regulatory Affairs Strategist to join our team at insitro. As a key member of our leadership team, you will be responsible for developing and implementing global regulatory strategies to support the development of multiple therapeutics and diagnostics.Key ResponsibilitiesRegulatory Strategy...

  • Lead Biostatistician

    4 weeks ago

    South San Francisco, California, United States Rigel Pharmaceutical Full time

    Job OverviewPOSITION SUMMARY: The Lead Biostatistician will provide advanced statistical methodologies and analytical support for various medical affairs initiatives by working closely with the medical affairs, clinical research, and Biometrics teams.KEY RESPONSIBILITIES:Utilizing innovative statistical methods to analyze data from completed studies to...

  • Senior/Vice President, Clinical Development, Immunology, Vividion Therapeutics

    3 weeks ago

    san diego, United States The Higgins Group, Inc. Full time

    Vividion Therapeutics seeks a decisive yet collaborative leader with deep translational and early clinical development experience in immunology to drive forward its pipeline of novel small-molecule precision medicines and build a first-class team. The S/VP, Immunology will be a highly visible leader within Vividion, responsible for both strategy and...

  • Senior/Vice President, Clinical Development, Immunology, Vividion Therapeutics

    4 months ago

    San Diego, United States The Higgins Group, Inc. Full time

    Vividion Therapeutics seeks a decisive yet collaborative leader with deep translational and early clinical development experience in immunology to drive forward its pipeline of novel small-molecule precision medicines and build a first-class team. The S/VP, Immunology will be a highly visible leader within Vividion, responsible for both strategy and...

VP, Biometrics/ Biostatistics

4 months ago

San Diego, United States Kumquat Biosciences Inc Full time
Job DescriptionJob DescriptionDescription:

At Kumquat, we strive to develop life changing medicines in an efficient and innovative way with the shared mission of patient focus in Oncology. The biometrics department plays an essential role in innovative clinical trial design and data quality delivery to bring better clinical trials to more patients and ultimately safe and effective drugs.


We want you to join our mission and be part of our passionate and collaborative community, We value individual and team accountability and also see the potential of all our people to learn, grow, develop and achieve great things beyond the confines of traditional descriptions.


This position reports to the Chief Medical Officer


VP of Biostatistics:

Who you are:


You are a talented and passionate human, inspired by our shared purpose to innovate clinical trial design and deliver life changing drugs to more patients.


You are an effective communicator that shares information transparently and strategically. You are comfortable working out loud and are an active listener.


You have strong interpersonal skills and thrive leading or being an active member of large or small diverse teams.

You thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient


Expectations:


Lead Biometrics group


Collaborate closely with Clinical Development to develop the optimal strategies to grow the portfolio and advance development programs


Oversee and lead input and execution of statistical analysis plans and assure statistical and data integrity and accuracy in clinical development plans, clinical protocol, clinical study reports, regulatory documents, publications and presentations


Provide support in working with regulatory responses to regulatory authority questions and preparation for regulatory authority meetings


Contribute to and present analyses to internal and external audiences including Safety Review Committees and independent Data Monitoring


Manage data release, review and participate in in QC and finalization of various documents


Build and resource the Biometrics team while providing leadership to team members including managing performances, developing people, hiring and integrating new team members


Establish best practices, identifying the needs and drive for the creation of standard operating procedures and work instructions.

Requirements:
  • PhD in Biostatistics or Statistics
  • Deep statistical and operational expertise, a proven ability to build and manage fully capable biometrics function
  • Understanding of regulatory guidelines for drug development, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • 10+ experience in clinical and drug development in the pharmaceutical/ biotech industry including trial design, regulatory submission/ approval experience and overseeing multiple molecules in various stages of development
  • Experience in oncology and hematological malignancies
  • Understanding of Phase I to Phase 3 drug development
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Prior people management experience and experience identifying organizational needs (talent, process, technology)
  • Expert in the principles and techniques of data analysis, interpretation and clinical relevance
  • Expert level of proficiency with SAS and / or other statistical software packages