Director – Statistics

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

📋 Description

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

• Influence the internal and external drug-development landscape utilizing analytical reasoning and therapeutic-area expertise.

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

• Advocate for cutting-edge statistical methodologies and their applications.

• Guide teams on significant risks and strategize resolutions; synthesize information and make informed, data-driven decisions.

• Contribute to study protocols, design studies, and author study-conduct protocols.

• Choose statistical techniques, draft protocol and statistical analysis plan sections, and execute analyses post-database creation.

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

• Stay updated and proficient in statistical methodologies while justifying the selected methods.

• Review the work of statistical colleagues critically.

• Guide team members on suitable research methodologies.

• Collaborate on reports and convey study outcomes.

• Present results through regulatory submissions, manuscripts, oral presentations, client discussions, and scientific meetings.

• Address regulatory inquiries and liaise with regulators.

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

• Execute work in accordance with relevant policies, procedures, processes, and training.

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

• Merge scientific reasoning and business acumen to identify issues, assess options, and execute solutions.

• Independently lead projects and effectively collaborate across functions.

• Leverage technical expertise to shape 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.

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

• 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 decisions.

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

• Resource management skills.

• Creativity and innovation.

• Proven problem-solving skills and critical thinking abilities.

• Expertise in business processes related to critical activities (e.g., regulatory submissions).

• Ability to adhere to relevant Corporate, Medical, local, and departmental policies, procedures, processes, and training.

🏝️ Benefits

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

• Company-sponsored 401(k).

• Pension plan.

• Vacation benefits.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• Prescription drug benefits.

• Flexible spending accounts for healthcare and/or dependent day care.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Employee assistance program.

• Fitness benefits.

• Employee clubs and activities.

• Disability accommodation support during the application process.

• Employee resource groups.