Summit Therapeutics, Inc.
Director, Biostatistics
Summit Therapeutics, Inc., Menlo Park, California, United States, 94029
2 weeks ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
About Summit
Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational About Summit
Ivonescimab, known as SMT112, 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. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.
Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:
HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting
.
Overview Of Role
Serves as the study-level biostatistician including reviewing protocol, conducting sample size calculations, developing statistical analysis plan, data presentation plan, and Data Monitoring Committee (DMC) charter, reviewing study documents (e.g., CRFs, ADaM specifications, statistical outputs, etc.) for clinical trials in oncology. Partners with cross-functional team members in ensuring accuracy/consistency of clinical data and exceptional delivery, interpretation of clinical results, and assists in the development and review of regulatory submission documents. Implements biostatistics department policies, standards, procedures, and work instructions.
Role And Responsibilities
Provide statistical support to clinical development through the conduct of clinical studies in oncology Conduct sample size calculations and develop statistical analysis plans (SAPs), data presentation plans, and DMC charters. Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan Review study documents (e.g., protocol, vendor data transfer specifications, ADaM specifications, statistical outputs) for clinical trials in oncology. Review the accuracy of clinical data, perform statistical analysis, ensure the application of appropriate statistical methods, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final clinical study reports Contribute to the preparation of manuscripts for publication, ensuring accurate statistical reporting of research findings. Develop and implement new statistical methodologies that enhance study design and analysis Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring. Independently defines required resources for assigned work, seeking advice as needed. Work with department leader to develop and implement department policies, standards and procedures Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and company SOPs.
Experience, Education And Specialized Knowledge And Skills
Ph.D. in Statistics, Biostatistics or equivalent area with 6+ years biopharmaceutical industry experience required. MS degree in related discipline with extensive industry and leadership experience (8+ years) can be considered. Strong proficiencies in software and other tools typically used by Biostatistics (e.g. SAS, R) Good understanding of clinical trial processes and statistical programming requirements Working knowledge of ICH, FDA and GCP regulations and guidelines Attention to detail, accuracy and confidentiality Clear and concise oral and written communication skills 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 Work in a fast-paced, demanding and collaborative environment
The pay range for this role is $163,000 to $191,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
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. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Strategy/Planning and Information Technology Referrals increase your chances of interviewing at Summit Therapeutics, Inc. by 2x Get notified about new Associate Director Biostatistics jobs in
Menlo Park, CA . San Jose, CA $248,000.00-$331,000.00 2 weeks ago San Jose, CA $132,000.00-$180,000.00 1 week ago Director | Analytics and Business Optimization
Senior Director, Business Insights and Analytics
Executive Director, Field Analytics & Insights
Director - Forecasting & Commercial Analytics
San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago Director Operations Intelligence & Analytics – Global Operations
Measurement Insights & Analytics Director
South San Francisco, CA $157,000.00-$291,600.00 6 days ago San Francisco Bay Area $201,200.00-$251,500.00 2 weeks ago Sunnyvale, CA $195,000.00-$481,000.00 1 week ago Director, Global Decision Sciences and Insights
San Francisco Bay Area $190,000.00-$220,000.00 2 weeks ago Head of Data Operations & Analytics - PayPal Ads
San Jose, CA $152,500.00-$262,350.00 2 months ago Senior Manager, Consumer Products Research & Insights
Foster City, CA $200,000.00-$250,000.00 1 week ago Sunnyvale, CA $254,000.00-$481,000.00 1 week ago Director, Operations Analytics and Workforce Management
Director, Strategy and Insights Enablement Lead (EPL)
Oakland, CA $200,000.00-$230,000.00 1 week ago Director, US Commercial Forecasting & Analytics - Epilepsy & Movement Disorder (Remote)
Sunnyvale, CA $208,000.00-$416,000.00 1 week ago VP, Head of Analytics, Data Science & Pricing
Palo Alto, CA $240,700.00-$447,500.00 3 weeks ago San Jose, CA $188,000.00-$323,950.00 2 weeks ago Senior Director, Business Insights and Analytics
South San Francisco, CA $245,000.00-$300,000.00 6 days ago Director, Commercial Analytics, HIV Prevention Integrated Insights
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational About Summit
Ivonescimab, known as SMT112, 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. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.
Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:
HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting
.
Overview Of Role
Serves as the study-level biostatistician including reviewing protocol, conducting sample size calculations, developing statistical analysis plan, data presentation plan, and Data Monitoring Committee (DMC) charter, reviewing study documents (e.g., CRFs, ADaM specifications, statistical outputs, etc.) for clinical trials in oncology. Partners with cross-functional team members in ensuring accuracy/consistency of clinical data and exceptional delivery, interpretation of clinical results, and assists in the development and review of regulatory submission documents. Implements biostatistics department policies, standards, procedures, and work instructions.
Role And Responsibilities
Provide statistical support to clinical development through the conduct of clinical studies in oncology Conduct sample size calculations and develop statistical analysis plans (SAPs), data presentation plans, and DMC charters. Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan Review study documents (e.g., protocol, vendor data transfer specifications, ADaM specifications, statistical outputs) for clinical trials in oncology. Review the accuracy of clinical data, perform statistical analysis, ensure the application of appropriate statistical methods, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final clinical study reports Contribute to the preparation of manuscripts for publication, ensuring accurate statistical reporting of research findings. Develop and implement new statistical methodologies that enhance study design and analysis Reviews and analyzes safety reporting, biomarker analyses and other aspects of clinical trial monitoring. Independently defines required resources for assigned work, seeking advice as needed. Work with department leader to develop and implement department policies, standards and procedures Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and company SOPs.
Experience, Education And Specialized Knowledge And Skills
Ph.D. in Statistics, Biostatistics or equivalent area with 6+ years biopharmaceutical industry experience required. MS degree in related discipline with extensive industry and leadership experience (8+ years) can be considered. Strong proficiencies in software and other tools typically used by Biostatistics (e.g. SAS, R) Good understanding of clinical trial processes and statistical programming requirements Working knowledge of ICH, FDA and GCP regulations and guidelines Attention to detail, accuracy and confidentiality Clear and concise oral and written communication skills 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 Work in a fast-paced, demanding and collaborative environment
The pay range for this role is $163,000 to $191,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
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. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Strategy/Planning and Information Technology Referrals increase your chances of interviewing at Summit Therapeutics, Inc. by 2x Get notified about new Associate Director Biostatistics jobs in
Menlo Park, CA . San Jose, CA $248,000.00-$331,000.00 2 weeks ago San Jose, CA $132,000.00-$180,000.00 1 week ago Director | Analytics and Business Optimization
Senior Director, Business Insights and Analytics
Executive Director, Field Analytics & Insights
Director - Forecasting & Commercial Analytics
San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago Director Operations Intelligence & Analytics – Global Operations
Measurement Insights & Analytics Director
South San Francisco, CA $157,000.00-$291,600.00 6 days ago San Francisco Bay Area $201,200.00-$251,500.00 2 weeks ago Sunnyvale, CA $195,000.00-$481,000.00 1 week ago Director, Global Decision Sciences and Insights
San Francisco Bay Area $190,000.00-$220,000.00 2 weeks ago Head of Data Operations & Analytics - PayPal Ads
San Jose, CA $152,500.00-$262,350.00 2 months ago Senior Manager, Consumer Products Research & Insights
Foster City, CA $200,000.00-$250,000.00 1 week ago Sunnyvale, CA $254,000.00-$481,000.00 1 week ago Director, Operations Analytics and Workforce Management
Director, Strategy and Insights Enablement Lead (EPL)
Oakland, CA $200,000.00-$230,000.00 1 week ago Director, US Commercial Forecasting & Analytics - Epilepsy & Movement Disorder (Remote)
Sunnyvale, CA $208,000.00-$416,000.00 1 week ago VP, Head of Analytics, Data Science & Pricing
Palo Alto, CA $240,700.00-$447,500.00 3 weeks ago San Jose, CA $188,000.00-$323,950.00 2 weeks ago Senior Director, Business Insights and Analytics
South San Francisco, CA $245,000.00-$300,000.00 6 days ago Director, Commercial Analytics, HIV Prevention Integrated Insights
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr