Director, Statistics

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the creation of clinical plans, pioneering study designs, statistical analyses, and interpretation of results at the program level.

• Shape both the internal and external environments to enhance the effectiveness of drug development by utilizing analytical thinking and knowledge of therapeutic areas.

• Enhance decision-making processes, pinpoint efficiencies, and boost the likelihood of technical success for projects.

• Advocate for innovative approaches using advanced statistical methodologies and applications.

• Guide the team on significant risks and strategies for resolution; integrate information and make data-driven decisions.

• Contribute to study protocols, design studies, and draft protocols for study execution.

• Choose statistical methods, write protocol and statistical analysis plan sections, and perform analyses.

• Collaborate with data sciences to develop data quality assurance plans.

• Stay updated with statistical methodologies and apply and justify new and diverse methods.

• Conduct peer reviews of work products produced by statistical colleagues.

• Work alongside team members to prepare reports and communicate findings.

• Present study results through regulatory submissions, manuscripts, oral presentations, direct customer communication, and scientific meetings.

• Address regulatory inquiries and engage with regulators.

• Comprehend disease states, competitive landscapes, and regulatory frameworks.

• Execute work in accordance with applicable corporate, medical, local, and departmental policies, procedures, processes, and training.

• Introduce and implement innovative methodologies and tools to address critical challenges.

• Combine scientific reasoning and business insights to identify issues, assess options, and implement solutions.

• Independently lead projects and collaborate effectively across functions.

• Utilize technical expertise to influence business decisions.

⛳️ Requirements

• Ph.D. in Statistics or Biostatistics.

• Minimum of 7 years of experience in clinical research and development within the Pharmaceutical Industry.

• Extensive experience with clinical trials, medical research, and/or real-world evidence.

• Proven track record of developing and sustaining a focus area in statistical or collaborative research.

• Proficient in statistical programming languages/software such as SAS, R, Spotfire, etc.

• Strong interpersonal communication skills for effective customer consultation and collaboration.

• Teamwork and leadership abilities; capacity to provide statistical guidance and technical expertise to influence business decisions.

• Self-management skills with an emphasis on achieving results for timely and accurate completion of competing deliverables.

• Resource management capabilities.

• Creativity and innovation.

• Demonstrated problem-solving skills and critical thinking.

• Business process knowledge related to essential activities, such as regulatory submissions.

🏝️ Benefits

• Company bonus based partially on both company and individual performance.

• Company-sponsored 401(k).

• Pension plan.

• Vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug benefits.

• Flexible benefits, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Various time-off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.