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
Partners with cross-functional team members in ensuring accuracy/consistency of clinical data and exceptional delivery, interpretation of clinical results
Assists in the development and review of regulatory submission documents
Implements biostatistics department policies, standards, procedures, and work instructions

Requirements

Ph.D. in Statistics, Biostatistics or equivalent area with 6+ years biopharmaceutical industry experience required
MS degree in related discipline with extensive industry and leadership experience (8+ years) can 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

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

biostatisticssample size calculationsstatistical analysis plandata presentation planregulatory submission documentsstatistical programming

Soft Skills

attention to detailaccuracyconfidentialityoral communicationwritten communicationmulti-taskingtime managementcollaboration

Certifications

Ph.D. in StatisticsPh.D. in BiostatisticsMS degree in related discipline