Principal Biostatistician

Description:

Precision Medicine Group is seeking a Principal Biostatistician to join their team in a fully remote, full-time role supporting all phases of clinical development. This role is ideal for a seasoned biostatistics professional with deep statistical knowledge, SAS programming expertise, and experience working directly with sponsors and cross-functional teams.

As a Principal Biostatistician, you will play a critical role in designing statistical methodologies, conducting data analyses, authoring reports, and guiding both internal and client-facing statistical strategies. You will also have the opportunity to lead statistical teams and support regulatory submissions across a wide range of therapeutic areas, particularly late-phase and complex trials.

Key Responsibilities:

• Develop and review statistical sections of protocols, especially for complex study designs.

• Provide sample size calculations and statistical support for adaptive designs and exploratory analyses.

• Design and implement statistical analysis plans (SAPs) including the creation of TLF (tables, listings, figures) shells.

• Program and review SAS datasets and outputs, ensuring quality control and regulatory compliance.

• Interact directly with sponsors, project managers, and global study teams to communicate statistical strategies and findings.

• Lead all statistical activities within project timelines, including budget oversight and team mentoring.

• Participate in business development activities including bid defense meetings and budget estimation.

• Support regulatory interactions, data monitoring committees (DMCs), and cross-functional internal teams.

• Maintain documentation in line with ICH, FDA, CDISC, and 21 CFR Part 11 standards.

Required Qualifications:

• Master’s degree in Statistics/Biostatistics (10+ years of experience) or PhD (7+ years).

• Expertise in SAS programming.

• Strong knowledge of regulatory requirements and industry standards (ICH, FDA, CDISC).

• Excellent consultative and interpersonal skills.

• Superior understanding of advanced statistical methodologies.

Preferred Qualifications:

• Experience in oncology and rare diseases.

• Involvement in late-phase clinical trials and regulatory submissions.

• Demonstrated ability to consult on study design and work with clients globally.

• Familiarity with adaptive designs and handling missing data.

Skills & Competencies:

• Advanced statistical analysis and presentation capabilities.

• Mastery in clinical trial principles and methodologies.

• Strong time management, decision-making, and problem-solving abilities.

• Service-oriented with a collaborative and flexible mindset.

• Outstanding written and spoken English communication skills.

Work Culture & Compliance:

• Inclusive work environment promoting equity and equal opportunities.

• Employees are expected to maintain professionalism and act as ambassadors of the organization.

• Must keep internal systems updated (timesheets, financial records, etc.).

• Fraud prevention awareness: Only legitimate hiring processes involve communication with Precision recruiters and formal interviews.