Senior Director, Biostatistics

About Summit:

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit's core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit's team is inspired to touch and help change lives through Summit's clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:

Non-small Cell Lung Cancer (NSCLC)

• HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

• HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

• HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China's National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role:


This position serves as the project level biostatistician providing technical leadership and statistical expertise to the design and execution of late-stage oncology clinical trials. They will contribute to protocol development, author the statistical analysis plans, conduct statistical analyses, and oversee biometrics activities for regulatory submissions. This position will collaborate 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. The Senior Director will develop and implements biostatistics department policies, standards, procedures, and work-instructions in coordination with department leader and other functions. They will represent biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies.


Role and Responsibilities:

• Provide technical leadership and statistical expertise in the design and execution of late-stage oncology clinical trials

• Contribute to protocol development, ensuring trial design, sample size, and statistical methodologies are appropriate and efficient

• Lead the development of statistical analysis plans, data presentation plans, clinical development plans, biometrics related submission activities, and post-submission strategies/responses

• Review clinical data for accuracy, perform statistical analyses, interpret study results, and collaborate with cross functional teams to produce interim and final reports, as well as 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

• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Ph.D. in Statistics, Biostatistics or a related field with 12+ years biopharmaceutical industry experience required. An MS degree in a related discipline with extensive industry and leadership experience (15+ years) may also be considered.

• 5+ years of experience in oncology clinical trials, including trial design and execution, with a strong background in late-stage clinical trials

• Deep understanding of clinical trial processes and statistical programming requirements for regulatory submissions (regulatory submission experience including NDAs/MAAs is required)

• Experience providing statistical support for Medical Affairs and Market Access activities is highly preferred

• Experience interacting with health authorities

• Technical expertise in statistical methodology and strong programming skills with SAS or R

• Excellent written and verbal communication skills and organizational skills

• Good working knowledge of ICH, FDA and GCP regulations and guidelines

• Attention to detail, accuracy and confidentiality

• Critical thinking, problem-solving abilities, and capacity to work independently

• Must be able to effectively multi-task, manage time-sensitive and highly confidential documents, and prioritize conflicting demands

• Comfortable working in a fast-paced, demanding and collaborative environment

This is the pay for this position

Pay Transparency

$246,000-$290,000 USD

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 Talent Acquisition team at View email address on click.appcast.io to obtain prior written authorization before referring any candidates to Summit.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.