Summit Therapeutics

Director, Biostatistics

Palo Alto, California, United States · Director

Sponsorship not specified$203k-$253kDetected 55 days ago

GCPStatisticsRecruitingClinical TrialsFDA RegulatorySASExperimental DesignLeadershipCommunicationCollaborationBiostatistics

About the role

Represents biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies.

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
Lead assessment and introduction of novel statistical methodologies to implement solutions
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

Write/review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and other regulatory processes
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.

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.

Experience in supporting oncology phase II/III clinical studies
Experience in organizing and driving regulatory submissions (e.g. NDA, sNDA, BLA)
In-depth knowledge of CDISC standards
Excellent written and verbal communication skills
Good working knowledge of ICH, FDA and GCP regulations and guidelines
This is the pay for this position
Pay Transparency
$203,000 - $253,000 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.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment.

$203,000 - $253,000 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.
The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Attend meetings with FDA or other health authorities to ensure ongoing agreement on project development

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