Executive Director Biostatistics

3 weeks ago

Menlo Park, United States Summit Therapeutics Sub, Inc. Full time
Job DescriptionJob Description

Location: Menlo Park, CA, or Remote West Coast US

Our Mission:

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission.

Summit Activities:


We have in-licensed ivonescimab (SMT-112), which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule taking advantage of cooperative binding between the two. We initiated multiple phase-III clinical studies in the following Lung cancer indications:

  • Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)
  • Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)


Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies.

Overview of Role:

Serves as the project level biostatistician and provides leadership within biostatistics function to develop and execute statistical strategy, study design, statistical analyses, and regulatory submissions for clinical trials in oncology. Partners with clinical science, regulatory and other team members in clinical development plans, authoring key clinical/regulatory/statistical documents, and ensuring exceptional delivery and interpretation of clinical data. Develops and implements biostatistics department policies, standards, procedures, and work-instructions in coordination with department leader and other functions. Represents biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies.

Role and Responsibilities:

  • Provide technical leadership and statistical support to clinical development through the design and conduct of clinical studies in oncology
  • Support/contribute to protocol development to ensure appropriateness of trial design, sample size, and propose the use of meaningful and efficient statistical methodologies
  • Lead development of statistical analysis plans, data presentation plans, clinical development plans, biometrics related submission activities, and post-submission strategies/responses
  • Review the accuracy of clinical data, perform statistical analysis, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final reports, and publications
  • Write/review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and other regulatory processes
  • Review vendor data transfer specifications and ADaM programming specifications
  • Lead assessment and introduction of novel statistical methodologies to implement solutions
  • Represent biostatistics function or biometrics department in cross function teams
  • Work with department leader to develop and implement department policies, standards and procedures
  • Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan
  • Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables and budgets
  • Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success
  • Attend meetings with FDA or other health authorities to ensure ongoing agreement on project development

Experience, Education and Specialized Knowledge and Skills:

  • Ph.D. in Statistics, Biostatistics or equivalent area with 15+ years biopharmaceutical industry experience required. MS degree in related discipline with extensive industry and leadership experience (18+ years) can be considered.
  • 15+ years of scientific programming experience with SAS or R.
  • Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions (regulatory submission experience including NDAs/MAAs is required).
  • Experience in providing statistical support for Medical Affairs and Market Access activities is highly preferred.
  • Demonstrated ability to provide insight into patterns within data which sheds new light on optimal ways in which treatments should be used. Excellent written and verbal communication skills
  • Good working knowledge of ICH, FDA and GCP regulations and guidelines
  • Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
  • Strong computer and database skills
  • Attention to detail, accuracy and confidentiality
  • Clear and concise oral and written communication skills
  • Excellent organizational skills
  • Critical thinking, problem solving, ability to work independently.
  • Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
  • Communicate effectively and articulate complex ideas in an easily understandable way
  • Prioritize conflicting demands.
  • Work in a fast-paced, demanding and collaborative environment

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.

  • Finance and Operations Director

    2 weeks ago

    Menlo Park, United States All Five Full time

    JOB TITLE: Finance and Operations Director REPORTS TO: Executive Director ABOUT ALL FIVE All Five is committed to building an equitable society beginning with the first five years of life. We believe all families, no matter their background, should have access to high-quality early childhood education for their children in a nurturing and respectful...

  • Finance and Operations Director

    2 days ago

    Menlo Park, United States All Five Full time

    JOB TITLE: Finance and Operations Director REPORTS TO: Executive Director ABOUT ALL FIVE All Five is committed to building an equitable society beginning with the first five years of life. We believe all families, no matter their background, should have access to high-quality early childhood education for their children in a nurturing and respectful...

  • Executive Administrative Partner

    1 week ago

    Menlo Park, United States Meta Platforms, Inc. Full time

    Meta is seeking an experienced Executive Administrative Partner to support up to 3 Directors in the Meta leadership team. The person in this role will need to be a masterful problem-solver and an organizational force given complex calendaring and heavy travel planning. Additionally, the ideal candidate will have exceptional communication skills, and will be...

  • Executive Administrative Partner

    1 day ago

    Menlo Park, United States Meta Platforms, Inc. Full time

    Meta is seeking an experienced Executive Administrative Partner to support up to 3 Directors in the Meta leadership team. The person in this role will need to be a masterful problem-solver and an organizational force given complex calendaring and heavy travel planning. Additionally, the ideal candidate will have exceptional communication skills, and will be...

  • Finance and Operations Director

    1 week ago

    Menlo Park, United States All Five Full time

     JOB TITLE:        Finance and Operations Director REPORTS TO:   Executive Director ABOUT ALL FIVEAll Five is committed to building an equitable society beginning with the first five years of life. We believe all families, no matter their background, should have access to high-quality early childhood education for their children in a nurturing...

  • Finance and Operations Director

    1 week ago

    Menlo Park, United States All Five Full time

     JOB TITLE:        Finance and Operations Director REPORTS TO:   Executive Director ABOUT ALL FIVEAll Five is committed to building an equitable society beginning with the first five years of life. We believe all families, no matter their background, should have access to high-quality early childhood education for their children in a nurturing...

  • Finance and Operations Director

    17 hours ago

    Menlo Park, United States All Five Full time

     JOB TITLE:        Finance and Operations Director REPORTS TO:   Executive Director ABOUT ALL FIVEAll Five is committed to building an equitable society beginning with the first five years of life. We believe all families, no matter their background, should have access to high-quality early childhood education for their children in a nurturing...

  • Finance and Operations Director

    2 days ago

    Menlo Park, United States All Five Full time

     JOB TITLE:        Finance and Operations Director REPORTS TO:   Executive Director ABOUT ALL FIVEAll Five is committed to building an equitable society beginning with the first five years of life. We believe all families, no matter their background, should have access to high-quality early childhood education for their children in a nurturing...

  • Executive Administrative Partner

    1 week ago

    Menlo Park, United States Facebook Full time

    Meta is seeking an experienced Executive Administrative Partner to support a VP and Director in the Meta leadership team. The person in this role will need to be a masterful problem-solver and an organizational force given complex calendaring and heavy travel planning. Additionally, the ideal candidate will have exceptional communication skills, and will be...

  • Executive Administrative Partner

    2 weeks ago

    Menlo Park, California, United States Facebook Full time

    Meta is seeking an experienced Executive Administrative Partner to support a VP and Director in the Meta leadership team. The person in this role will need to be a masterful problem-solver and an organizational force given complex calendaring and heavy travel planning. Additionally, the ideal candidate will have exceptional communication skills, and will be...

  • Executive Administrative Partner

    2 weeks ago

    Menlo Park, United States Meta Platforms, Inc. Full time

    Meta is seeking an experienced Executive Administrative Partner to support three Directors in the Meta leadership team. The person in this role will need to be a masterful problem-solver and an organizational force given complex calendaring and heavy travel planning. Additionally, the ideal candidate will have exceptional communication skills, and will be...

  • Executive Administrative Partner

    1 day ago

    Menlo Park, United States Meta Platforms, Inc. Full time

    Meta is seeking an experienced Executive Administrative Partner to support three Directors in the Meta leadership team. The person in this role will need to be a masterful problem-solver and an organizational force given complex calendaring and heavy travel planning. Additionally, the ideal candidate will have exceptional communication skills, and will be...

  • Executive Administrative Partner

    1 day ago

    Menlo Park, California, United States Facebook Full time

    Meta is seeking an experienced Executive Administrative Partner to support a VP and Director in the Meta leadership team. The person in this role will need to be a masterful problem-solver and an organizational force given complex calendaring and heavy travel planning. Additionally, the ideal candidate will have exceptional communication skills, and will be...

  • Executive Director of Development

    4 weeks ago

    College Park, United States University of Maryland Full time

    The Executive Director of Development (EDOD) is an essential administrator in the Division of University Relations and a strategic leader in the planning and execution of annual fundraising goals and university-wide fundraising campaigns. The Executive Director directs a portfolio of fundraising programs within the Central Development organization: Regional...

  • Executive Administrative Partner, Analytics

    2 weeks ago

    Menlo Park, United States Meta Platforms, Inc. Full time

    Meta is seeking an experienced Executive Administrative Partner to support 3 Directors on the Monetization Analytics team. The person in this role will need to be a masterful problem-solver and an organizational force given complex calendaring across multiple organizations. The ideal candidate will have exceptional communication skills, and will be...

  • Executive Administrative Partner, Analytics

    2 days ago

    Menlo Park, United States Meta Platforms, Inc. Full time

    Meta is seeking an experienced Executive Administrative Partner to support 3 Directors on the Monetization Analytics team. The person in this role will need to be a masterful problem-solver and an organizational force given complex calendaring across multiple organizations. The ideal candidate will have exceptional communication skills, and will be...

  • Executive Director of Development

    2 weeks ago

    College Park, United States University of Maryland Full time

    **Posting Details**: - Posting Details**Position Number**: - 117861**Title**: - Executive Director**Functional Title**: - Executive Director of Development**Category Status**: - 33-Exempt Regular**Applicant Search Category**: - Staff**University Authorized FTE**: - 1.000**Unit**: - VPUR-Development**Campus/College Information**: - Founded in 1856,...

  • Associate Director, Clinical Quality Assurance

    2 weeks ago

    Menlo Park, United States Abdera Therapeutics Full time

    Who we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing...

  • Associate Director, Clinical Quality Assurance

    2 days ago

    Menlo Park, United States Abdera Therapeutics Full time

    Who we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing...

  • Director - Decision Support

    7 days ago

    Menlo Park, California, United States Stanford Health Care Full time

    If you're ready to be part of our legacy of hope and innovation, we encourage you to take the first step and explore our current job openings. Your best is waiting to be discovered. Day - 08 Hour (United States of America)This is a Stanford Health Care job.A Brief OverviewThe Director of Decision Support is a senior member of the Decision Support team,...