Principal Biostatistician (Contract)

How you’ll make an impact:

The Principal Biostatistician role will be responsible for the statistical activities for multiple clinical studies, participating in protocol development and executions, ensuring compliance with SOPs to produce quality and timely statistical deliverables.

About the team:

You'd be a part of our amazing Biometrics team while also working cross functionally with other teams!

How you’ll spend your time:

• Serve as a study biostatistician for multiple clinical studies
• Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
• Author statistical analysis plans for studies, and author/edit shells for tables, figures and listings
• Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
• Provide statistical input to data monitoring committee (DMC) charters, project management plans, and other study-level documents
• Work with statistical programmers or CROs to generate tables, figures and listings
• Support ongoing safety review and DMC review of the clinical development program/study teams
• Perform ad hoc and exploratory statistical analyses as needed
• Contribute to clinical study reports, including authoring of statistical sections, interpretation of the study results, and QC of the results in the reports.
• Support regulatory submissions as needed
• Support the preparation of publications, including manuscripts, posters and oral presentations
• Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs

Who you are and what you’ve accomplished:

• MS in biostatistics or equivalent with at least 9 years of relevant clinical trial experience or PhD in biostatistics or equivalent with at least 6 years relevant clinical trial experience.
• Knowledge of statistical methods for clinical trials
• Proficient in statistical programming (SAS is required, and R is a plus)
• Ability to communicate above and below level in a way that fosters relationship building, including cross-functional teams, and external relationships with vendors
• Successfully worked in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
• Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities
• Embraces and models our core values—re:think, have:heart, better:2gether, time:is now

Contract Term: 12 Months