Sr Manager, Biostatistics (Study Lead)

Role Summary

Biostatistics Study lead: As a Statistical Science Study Lead, the Senior Manager is responsible for leading and managing all Statistical Science-related activities for one or more studies of a comprehensive program to ensure high-quality deliverables are executed in line with agreed timelines.

Responsibilities

• Provide statistical leadership, as a member of cross-functional study team, during protocol development (study design, sample size justification, and safety/efficacy analysis methods) and throughout study duration
• Collaborate with key stakeholders on study design and develop statistical analysis plan
• Analyze and validate data to support study deliverables, including filings, reports, publications, and presentations
• Provide leadership and oversight for all Data Science deliverables for the study
• Chair, or select a delegate to chair, Data Science functional and cross-functional program teams (Statistical Analysis and Review Team) to ensure appropriate cross-functional collaboration, communication, and input into program deliverables and outcomes
• Communicate Statistical Science and/or Data Science guidance as a representative in cross-functional study teams
• Lead, and collaborate with others in Data Science, in the development of the statistical analysis plan for the study including endpoint definition, sample size justification and statistical methodology; lead the execution of statistical analysis activities as outlined in the SAP
• Collaborate with others in Data Science and cross-functional stakeholders on study design
• Develop or contribute to the development of study-related deliverables: study protocols, case report forms, data quality reviews and analyses, manuscripts, and sections of clinical study reports
• Contribute to and negotiate study timeline with cross-functional team; identify Statistical Science study resource needs to meet timeline
• Provide statistics area expertise to study team activities and deliverables
• Serve as the statistical expert for the study throughout the study lifecycle and ensure accuracy and reliability of statistical results
• Work with cross-functional study team members and statisticians to analyze and interpret clinical study data
• Identify and manage issues and risks and escalate as appropriate
• Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the program
• Follow Statistical Science processes for study execution for all Statistical Science-related study deliverables
• Develop SOPs, WIs, guidelines, and templates

Qualifications

• PhD degree preferred, or MS in statistics, biostatistics or related discipline
• 3+ years clinical trial experience in pharmaceutical and/or biotech company with PhD; 6+ years with MS
• Experience with statistical analysis plans, study protocols, clinical study reports, integrated safety and efficacy narratives, Investigator Brochures, and annual reports; familiarity with electronic submissions (eCTD, NDA/BLA) and regulatory interactions
• Strong programming skills in SAS, R, and other statistical software packages

Education

• PhD preferred; or MS in statistics/biostatistics or related field

Skills

• Statistical leadership and cross-functional collaboration
• Study design and SAP development
• Data analysis, interpretation, and reporting
• Regulatory submission support and communication