Director, Medical Affairs Biostatistics

BioTalent Ltd; Bridgewater Township (SD); Remote; USD 90,000 - 150,000; Full time

Job summary

An established healthcare organization is on the lookout for a seasoned statistical leader to join its innovative Medical Affairs team. This role is pivotal in ensuring the scientific rigor of statistical input across various studies and publications. As part of a collaborative biometrics team, you will lead statistical strategies for therapeutic programs, manage complex analyses, and mentor junior members. This position offers a unique opportunity to influence real-world data initiatives while working primarily in a remote capacity with occasional in-person meetings. If you have a passion for statistical excellence and want to make a significant impact in healthcare, this role is for you.

Qualifications

• 8+ years of relevant industry experience in statistical leadership.
• Comprehensive understanding of drug development lifecycle.

Responsibilities

• Lead statistical strategy for therapeutic programs within Medical Affairs.
• Manage timelines and quality across statistical analyses.

Skills

Statistical Methodologies

Clinical Research Design

Data Analysis with SAS

Data Analysis with R

Project Leadership

Cross-Functional Collaboration

Education

Doctorate in Statistics

Doctorate in Biostatistics

Tools

SAS

R

Job description

Position Summary
An established healthcare organization is seeking a seasoned statistical leader to support post-approval research and evidence generation within its Medical Affairs function. This individual will play a critical role in ensuring the scientific rigor and quality of statistical input across observational studies, health technology submissions, and scientific publications. The role sits within a collaborative and evolving biometrics team focused on real-world data and post-marketing insights.

Key Responsibilities

• Lead statistical strategy and execution for one or more therapeutic programs within Medical Affairs.

• Serve as the primary statistical representative on cross-functional teams, ensuring robust analytical plans for post-approval studies and external dissemination of data.

• Manage timelines, deliverables, and quality across internal and outsourced statistical analyses.

• Apply and oversee advanced statistical methodologies for real-world and observational research, ensuring scientific validity and regulatory readiness.

• Foster collaboration across data science, clinical, and medical functions to embed statistical thinking into key initiatives.

• Support internal innovation and development through participation in broader departmental initiatives.

• Mentor junior team members and provide subject matter expertise as needed.

Qualifications

• Doctorate in Statistics, Biostatistics, or a related field, with 8+ years of relevant industry experience.

• Comprehensive understanding of the drug development lifecycle, especially in the post-approval phase.

• Proficient in designing and analyzing clinical research using tools such as SAS and R, with working knowledge of industry data standards (e.g., SDTM, ADaM).

• Demonstrated experience with observational studies, real-world data analyses, and HTA dossier preparation.

• Strong project leadership, communication, and cross-functional collaboration skills.

• Ability to synthesize complex statistical ideas into actionable insights for diverse stakeholders.

• Limited travel required (~10%); primarily remote with periodic in-person meetings.