Social & Scientific Systems (S-3)

Director of Biostatistics

US-MD-Silver Spring
Job ID
2017-1696
Category
Clinical
Type
Regular Full-Time

Overview

Social & Scientific Systems (SSS) works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients. The SSS team offers a synergy of expertise in clinical research services, epidemiology and public health studies, health data management and analysis, and program evaluation and policy analysis. Please join our dedicated staff of employee-owners in an environment that values diversity and supports health, well-being, and professional growth.

 

The Director of Biostatistics will provide leadership and guidance as the statistical expert within CRB. The Director will be accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. The Director will provide strategic, operational, and implementation oversight of biostatistics for clients and will participate in producing the long-range strategic plans for developing biostatistics capabilities for CRB. Programs will involve frequent interactions with biostatistics thought leaders, pharmaceutical and biotech companies, and investigators at a global level. In this role, the Director will take on leadership responsibility for developing, securing, managing, and executing biostatical project management. Responsibilities include ensuring operational capabilities to execute therapeutic area expansion and representing both SSS Business Development and Biostatistics capabilities in bid defenses and at other critical client meetings. The Director also will be a key statistical consultant within the company.

Responsibilities

  • Participates in strategic and operations planning for SSS; implements and maintains operating plans and annual implementation plans to meet corporate strategic goals and objectives.
  • Maintains awareness of industry standards, regulatory requirements, and SOPs. Within area of control, updates procedures and practices as needed to remain in compliance.
  • Directs and interacts strategically with cross-functional teams and other functional areas to ensure timely delivery of project deliverables with consistent high performance and quality of work. Works with other functional personnel to appropriately staff project teams.
  • Reviews and approves topline results memos and statistical conclusions. Provides guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Oversees execution of statistical analyses, preparation of the statistical methods and results sections for clinical study reports, and production of overall summaries. Ensures statistical representation at regulatory, client, and other external meetings.
  • Provides general guidance on definition and documentation of key derived variables needed to support production of tables, figures, and listings; effects consistency of data collection and analysis.
  • Plans and tracks project activities, timelines, and resource use across projects. Provides justification for planned resource needs. Seeks to optimize resource utilization and capacity.
  • Ensures mentoring and development of staff. Encourages professional development in the context of project work. Learns and applies techniques to promote teamwork, quality, and motivation.
  • Determines Biostatistics group goals and resource allocation in conjunction with the Group Vice President.
  • Performs additional duties as required.

Qualifications

  • Ph.D. in statistics or related discipline with 10+ years of progressive experience in the biotechnology, pharmaceutical, or health-related industry, including significant interactions with regulatory bodies, history of successful management (5+ plus years), and expertise in one or more therapeutic areas
  • Proven ability to work in a changing and busy environment and to exercise judgment in interpreting, modifying, and adapting procedures, practices, and methods in accordance with existing policies and standards for application to specific problems or tasks. Effective at working independently—self-directed, with high energy and a strong work ethic. High degree of creativity, latitude, and attention to detail is required.
  • Strong leadership, project management, teamwork, and interpersonal skills.
  • Broad knowledge and superior understanding of advanced statistical concepts and techniques.
  • Ability to apply technical principles, theories, and concepts in an innovative manner to pharmaceutical clinical development and life cycle management.
  • Proven success, through previous submissions or interactions, in meeting regulatory guidelines and requirements for drug development.
  • In-depth understanding of the regulatory drug submission/approval process
  • Ability to effectively represent Biostatistics and Data Management in multidisciplinary or cross-functional meetings.
  • Experience with managing direct reports, contractors, teams, external agencies, consultant groups, and research committees.
  • Ability to recruit, retain, motivate, and develop highly qualified persons.
  • Experience in providing effective expert advice to senior-level staff.
  • Ability to work in a fully self-directed manner.
  • Expertise in SAS, S-Plus/R, and sample-size calculation software (e.g., East and nQuery).

SSS is committed to fostering a diverse workforce and is proud to be an Affirmative Action/Equal Opportunity Employer of Minorities/Women/Protected Veterans/Individuals with Disabilities. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex, age, national origin, veteran status, disability, or any other classification protected by law.

 

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