Associate Director, Biostatistics

Summit Therapeutics; Palo Alto (CA); On-site; USD 190,000 - 210,000; Full time

Benefits offered by this job

Bonus and stock options

Health benefits

Work-life balance initiatives

Job summary

Summit Therapeutics in Palo Alto is looking for a Biostatistician to support oncology clinical trials by providing statistical analyses and collaborating with cross-functional teams. The ideal candidate will hold a Ph.D. in Statistics or Biostatistics along with significant industry experience.

This role requires proficiency in SAS and R, comprehensive understanding of clinical trial processes, and exceptional communication skills. A diverse and inclusive work environment is strongly advocated at Summit Therapeutics.

Qualifications

• Ph.D. in Statistics, Biostatistics, or equivalent area with 6+ years biopharmaceutical industry experience.
• Strong proficiencies in SAS and R.
• Knowledge of ICH, FDA, GCP regulations.

Responsibilities

• Provide statistical support for clinical studies.
• Conduct sample size calculations and develop SAPs.
• Ensure accuracy and consistency of clinical data.

Skills

SAS

R

Statistical analysis

Attention to detail

Communication skills

Education

Ph.D. in Statistics or Biostatistics

Master’s degree in related discipline

Job description

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving serious unmet medical needs.

Overview of Role

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. 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.

Role and Responsibilities

• 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 (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
• Contribute to the preparation of manuscripts for publication, ensuring accurate statistical reporting of research findings.
• Develop and implement new statistical methodologies that enhance study design and analysis
• Review and analyze safety reporting, biomarker analyses and other aspects of clinical trial monitoring.
• Independently defines required resources for assigned work, seeking advice as needed.
• Work with department leader to develop and implement department policies, standards and procedures
• Adheres to regulatory requirements of study conduct, statistical analysis principles, industry standards, and company SOPs.

Experience, Education and Specialized Knowledge and Skills

• Ph.D. in Statistics, Biostatistics or equivalent area with 6+ years biopharmaceutical industry experience required. Master’s degree in a related discipline with extensive industry and leadership experience (8+ years) may 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

Pay Transparency

$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.

Equal Opportunity Employer Statement

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