Principal Biostatistician

Precision Medicine Group is seeking a Principal Biostatistician to provide statistical support for all phases of clinical development. The role involves writing and reviewing statistical sections of protocols and analysis plans, conducting statistical analyses, presenting results, and developing SAS programs.

Responsibilities include:

• Generating and verifying randomization schedules.
• Developing and reviewing statistical methods for clinical study protocols.
• Performing sample size calculations.
• Providing input into the development of case report forms (CRFs).
• Authoring and reviewing statistical analysis plans.
• Generating analysis datasets, tables, figures, and listings using SAS.
• Performing quality control for statistical SAS programs.
• Providing statistical support for regulatory agencies and ad-hoc requests.
• Serving as a biostatistical consultant to company staff globally.
• Reviewing statistical sections of clinical study reports.
• Interacting with sponsors, project managers, and external vendors.
• Leading all statistical activities for studies within timelines.
• Performing budget health reviews and reviewing monthly invoices.
• Assisting with budget development and presenting at bid defense meetings.
• Participating in the development and maintenance of departmental procedures and standards.

Requirements:

• Master's degree in Statistics, Biostatistics, or related field with 10+ years of experience; or PhD degree with 7+ years of experience.
• Experience with SAS.
• Knowledge of industry standards (ICH guidelines, CDISC, 21 CFR Part 11, FDA guidelines).
• Broad knowledge of advanced statistical concepts and techniques.

The role offers:

• Opportunity to work remotely.
• Chance to lead statistical activities for studies.
• Involvement in budget development and presentations.
• Participation in the development of departmental procedures and standards.