Associate Director, Biostatistics

Summit Therapeutics Inc.; Miami (FL); On-site; USD 174,000 - 203,000; Full time

Job summary

Summit Therapeutics Inc. seeks a senior biostatistician to lead statistical strategy and analyses for oncology trials. You will partner with clinical science, regulatory, and other teams to design studies, prepare submissions, and ensure rigorous interpretation of data.

You will develop department policies, coordinate with CROs, and oversee data quality, ADaM programming, and regulatory responses. A Ph.D. or equivalent with biopharma leadership is required.

Qualifications

• Ph.D. in Statistics or Biostatistics with 6+ years in biopharmaceuticals.
• Strong proficiency in SAS and R for analyses and reporting.
• Working knowledge of ICH, FDA and GCP regulations.

Responsibilities

• Provide technical leadership and statistical support for oncology trials.
• Lead development of SAPs and data presentation plans.
• Review data, perform analyses, and interpret results for reports.
• Prepare regulatory sections and respond to inquiries during submissions.
• Collaborate with CROs, data management, and clinical teams.

Skills

Biostatistics leadership

SAS

R

Statistical analysis

Regulatory communication

Education

Ph.D. in Statistics/Biostatistics

MS in related discipline

Tools

SAS

R

Job description

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.

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:

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
• All other duties as assigned

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

This is the pay for this position

Pay Transparency

$174,000 - $203,000 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 [e-mail] 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.

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Summit Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.