Director, Statistics

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

📋 Description

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

• Integrate analytical thinking with therapeutic area expertise to enhance the efficiency of drug development.

• Leverage statistical knowledge to support decision-making, pinpoint efficiencies, and boost the likelihood of technical success.

• Advocate for pioneering approaches through innovative statistical methodologies and applications.

• Guide teams on significant risks and resolution strategies; synthesize information to make data-driven decisions.

• Contribute to study protocols and design various studies.

• Draft protocols for the execution of each study.

• Choose statistical methods for analyzing data.

• Author sections of protocol and statistical analysis plans.

• Perform analyses following the establishment of the reporting database.

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

• Stay updated on statistical methodologies and apply new techniques with justification.

• Conduct peer reviews of the work products produced by other statisticians.

• Guide team members on suitable research methodologies.

• Collaborate on reports and convey study findings.

• Present results through regulatory submissions, manuscripts, oral presentations, individual consultations, and scientific meetings.

• Address regulatory inquiries and engage with regulatory bodies.

• Utilize knowledge of disease states, competitive landscapes, and regulatory environments.

• Ensure compliance with relevant corporate, medical, local, and departmental policies, procedures, processes, and training.

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

• Combine scientific reasoning with business acumen to identify problems, assess options, and execute solutions.

• Independently lead projects and collaborate effectively across various functions.

• Utilize technical expertise to impact business decisions.

⛳️ Requirements

• Ph.D. in Statistics or Biostatistics.

• A 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.

• A proven history of developing and maintaining a domain of statistical or collaborative research.

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

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

• Teamwork and leadership capabilities; ability to provide statistical guidance and technical expertise to influence business outcomes.

• Self-management skills focused on achieving results for timely and precise completion of competing deliverables.

• Skills in resource management.

• Innovative mindset and creativity.

• Proven problem-solving skills and critical thinking abilities.

• Expertise in business processes associated with critical activities, including regulatory submissions.

🏝️ Benefits

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

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

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

• Flexible benefits options, including healthcare and/or dependent day care flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

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