Director – Statistics

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

📋 Description

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

• Influence both internal and external drug-development landscapes through analytical thinking and expertise in therapeutic areas.

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

• Advocate for the use of innovative statistical methodologies and their applications.

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

• Contribute to study protocols and assist in designing studies.

• Draft protocols for the conduct of studies.

• Choose statistical methods for data analysis.

• Write sections of protocols and statistical analysis plans.

• Perform analyses after the creation of the reporting database.

• Collaborate with data sciences on plans for data quality assurance.

• Stay updated on current statistical methodologies and enhance proficiency with new methods.

• Review the work products of statistical colleagues.

• Guide team members on suitable research methodologies.

• Work together on reports and communicate study findings.

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

• Address regulatory inquiries and engage with regulators.

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

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

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

• Combine scientific reasoning and business acumen to pinpoint issues, assess options, and apply solutions.

• Independently lead projects and collaborate effectively across various functions.

• Utilize technical expertise to shape business decisions.

⛳️ Requirements

• Ph.D. in Statistics or Biostatistics.

• Over 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 history of developing and maintaining a statistical or collaborative research area.

• Experience working with Data Monitoring Committees (DMC).

• Background in contributing to IND, BLA, or NDA submissions, including direct engagement with regulatory agencies such as the FDA and EMA.

• Experience in gene therapy, rare diseases, and/or ophthalmology clinical development.

• Proficiency in statistical programming languages/software such as SAS, R, and Spotfire.

• Strong interpersonal communication skills for effective customer consultations and collaborations.

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

• Self-management skills focused on the timely and precise completion of competing deliverables.

• Resource management capabilities.

• Creativity and a penchant for innovation.

• Demonstrated problem-solving skills and critical thinking abilities.

• Expertise in business processes relevant to critical activities such as regulatory submissions.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Comprehensive medical benefits.

• Dental benefits.

• Vision benefits.

• Prescription drug benefits.

• Flexible benefits, 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, including an employee assistance program, fitness benefits, and employee clubs and activities.

• Employee resource groups (ERGs).

• Disability accommodation support during the application process.