Principal Statistical Analyst

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 Principal Statistical Analyst will be responsible for supporting and/or leading the statistical programming activities for clinical trial data collection, analysis, reporting, visualization on all Summit drugs. Produce, review program codes and suggest alternative solutions that may be efficient. Allocate resource for project, manage project timeline, control quality of deliverables and ensure compliance of procedure. Interact with statisticians, data management, clinicians, medical writers, medical affairs personnel, and other members of Summit regulatory.

Role and Responsibilities

Works closely with Biostatistics to implement statistical analysis of clinical trial data, working closely on the development and validation of ADaM specifications and datasets, and TLFs for analyses to support regulatory, medical affairs, and market access needs

Consolidate heterogeneous data source (e.g. clinical study databases, external databases, real world data) to prepare analysis-ready datasets supporting a particular project, study deliverable

Work closely with Biostatistician to implement CDISC SDTM and ADAM specification datasets

Perform compliance check and resolve any compliance issue during the process

Create documentation for regulatory filings including reviewers guides and data definition documents and ensure compliance per FDA guideline

Perform data analysis, statistical analysis, generate safety and efficacy tables, figures and listings using Base SAS, SAS macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/OD

Review Data Management Plan, Data monitoring plan and edit check specification

Implement data monitoring listings and SAS edit check to support team data monitoring

Evaluate scope of work for project or ad hoc requests on resource allocation, timeline buildup, and become the stakeholder on delivery

Validate work of other programmer/analysts at CRO or in-house to ensure appropriate validation process

Create, debug, validate or maintain company level macros that streamline repetitive operations to increase programming efficiency

Act as a liaison in study team between statistical programming, and other functional teams as needed

Leads or participates in the development of standard operating procedures (SOP)

Work on improving the efficiency and quality of existing workflows and mentors Statistical Programmers and Statistical analysts

All other duties as assigned

Experience, Education and Specialized Knowledge and Skills

Bachelor’s or Master’s degree in Biostatistics, statistics, computer science or related field

Minimum 7+ years Pharmaceutical/Biotech programming experience. Experience working with Oncology trials preferred

Solid knowledge on CDISC standards including (SDTM, ADaM)

Good understanding and hands on experience on programming support for data monitoring and data clean/query process

Good understanding on clinical data coding dictionaries (MedDRA and WHODD)

High degree of technical competence and communication ability, both oral and written. Competent in SAS programming and Macro development

Working knowledge of current regulatory requirements and ICH guidance with deep understanding on clinical trial compliance requirements; Knowledge of Pinnacle 21

Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA, NDA/BLA or other regulatory filling experience, including ISS or ISE experience

The ability to work well under pressure and shifting priorities, both as a team leader and as a team member

The ability to plan, execute and manage project resources, timeline, and delivery with good skill on setting priorities

Ability to proactively identify and address project uncertainties to minimize risk

Strong problem solving and analytical skills

Fluency in 2 or more or relevant programming languages, such as R, Python will be plus

Ability to communicate clearly both oral and written

This is the pay for this positionPay Transparency$10—$20 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 <[email hidden]></