Back to jobs

Associate Director, Statistical Programming

Palo Alto, CA (US)

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:

The Associate Director, Statistical Programming will be responsible for leading and managing the statistical programming activities for clinical trial data collection, analysis, reporting, and visualization, with a primary focus on oncology studies. This role will oversee the development and implementation of statistical programming strategies, manage a team of statistical programmers, and collaborate closely with cross-functional teams to ensure high-quality deliverables that meet regulatory requirements and support drug development efforts.

Role and Responsibilities:

  • Lead and manage statistical programmers, providing mentorship, technical guidance, and career development opportunities.
  • Develop and implement statistical programming strategies and best practices for clinical trials across all phases, ensuring alignment with company goals, industry standards, and regulatory requirements.
  • Oversee the creation and validation of CDISC-compliant SDTM and ADaM datasets, with a focus on oncology-specific data structures and endpoints.
  • Collaborate with Biostatistics to implement complex statistical analyses for oncology trials, including time-to-event analyses, response evaluations, and biomarker assessments.
  • Direct the development of tables, listings, and figures (TLFs) for clinical study reports, regulatory submissions (including NDA/BLA), and publications.
  • Ensure compliance with FDA, EMA, PMDA and other regulatory agency requirements for statistical programming deliverables in submissions.
  • Lead the development and maintenance of standardized oncology-specific analysis datasets, programs, and macros to improve efficiency and consistency across projects.
  • Manage resource allocation, project timelines, and deliverables for multiple studies simultaneously, including outsourced work to CROs.
  • Serve as the statistical programming representative in cross-functional study teams and external collaborations.
  • Contribute to the development and improvement of department SOPs, working instructions, and quality control processes.
  • Stay current with evolving trends in oncology clinical trials, statistical methodologies, and programming techniques, and implement innovative approaches as appropriate.
  • Contribute to regulatory interactions and represent statistical programming in regulatory meetings when needed.
  • All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

  • Master's degree in Statistics, Biostatistics, Computer Science, or a related field.
  • Minimum of 12+ years of experience in statistical programming within the pharmaceutical/biotech industry, with at least 5+ years focused on oncology trials and 3+ years in a leadership role.
  • Extensive experience with CDISC standards (SDTM, ADaM, define.xml) and their application in clinical studies across all phases.
  • Strong proficiency in SAS programming, including macro development, ODS graphics, and experience with SAS/STAT procedures.
  • In-depth knowledge of oncology-specific endpoints, such as progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and RECIST criteria.
  • Experience with statistical analysis methods commonly used in oncology trials, including time-to-event analyses, and methods for handling missing data.
  • Thorough understanding of regulatory requirements for statistical programming in submissions to FDA, EMA, PMDA, and other health authorities.
  • Experience in preparing and reviewing key documents for regulatory submissions (e.g., SAP, ADaM spec, Define files, Reviewer's Guide).
  • Demonstrated experience in leading and managing statistical programming teams, including experience with global and/or outsourced teams.
  • Strong project management skills, with the ability to prioritize and manage multiple studies simultaneously.
  • Excellent problem-solving skills and the ability to provide innovative solutions to complex programming challenges in clinical research.
  • Strong communication skills, both written and verbal, with the ability to effectively communicate technical concepts to non-technical stakeholders.
  • Experience with R and Python programming languages is highly desirable.
  • Familiarity with data standards organizations (e.g., CDISC, PhUSE) and industry initiatives.

Preferred Qualifications:

  • Experience with oncology immunotherapy trials and associated efficacy endpoints (e.g., iRECIST).
  • Knowledge of electronic data capture (EDC) systems and clinical data management processes.
  • Experience with data visualization tools (e.g., R Shiny, Spotfire, Tableau).
  • Familiarity with cloud-based computing environments and big data technologies.
  • Active participation in industry conferences and working groups.

 

This is the pay for this position

Pay Transparency

$175,000 - $205,000 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 recruiting@smmttx.com 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.

Create a Job Alert

Interested in building your career at Summit Therapeutics? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

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 hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential 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.

Select...
Select...
Race & Ethnicity Definitions

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 measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is 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.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.