Summit Therapeutics

Associate Director, Biostatistics

Palo Alto, California, United States · Director

Sponsorship not specified$190k-$210kDetected 55 days ago

GCPStatisticsRecruitingClinical TrialsFDA RegulatorySASResearchExperimental DesignLeadershipCommunicationCollaborationBiostatistics

About the role

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.
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.

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
Develop and implement new statistical methodologies that enhance study design and analysis
Work with department leader to develop and implement department policies, standards and procedures

Independently defines required resources for assigned work, seeking advice as needed.

Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

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
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
$190,000 - $210,000 USD
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.

$190,000 - $210,000 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.

Experience, Education and Specialized Knowledge and
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.
Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment.

This listing is sourced directly from Summit Therapeutics's careers page and normalized into a canonical job model.