Associate Director, Biostatistics

1/10/23

Gaithersburg, MD

1894

Responsible for providing statistical leadership and to the clinical development of molecules. The incumbent in this role will actively participate in and contribute to and influence strategic discussions and planning of clinical development of molecules. He/she will lead statistical support efforts for protocol design and study activities of clinical studies, represent biostatistics in regulatory interactions, and proactively identify the needs for and significantly contribute to departmental infrastructure improvement projects to better serve objectives.

Responsibilities and Job Duties

  • Provides leadership to clinical teams as lead biostatistician on multiple clinical studies/compounds and provides statistical leadership and influence in clinical development of molecules
  • Writes and reviews statistical sections of protocols, statistical analysis plans, statistical programming plans, clinical study reports, and other study related documents, and performing statistical design, simulation and analysis of clinical studies
  • Assures that the biostatistics aspects of trial design, conduct, analysis, data reporting and data interpretation are conducted in an accurate, efficient, ethical and complete manner
  • Identifies the needs for, and contributes to departmental infrastructure improvement projects
  • Collaborates with Data Management on the development and review of CRFs, data cleaning, and database design, with Statistical Programming on the development of data outputs (TLF shells) and reporting database, as well as providing guidance on statistical programming
  • Contributes to the preparation of regulatory documents (meeting request, briefing documents, etc), is responsible for the statistical aspect of regulatory submission (ISS, ISE, IND, BLA, etc), and represents biostatistics in regulatory interactions
  • Serves as technical expert and provides technical advice to junior biostatisticians

Minimum Qualifications

Education & Other Credentials

Associate Biostatistics Director

  • A Ph.D. degree in Biostatistics or related field with a minimum of 8 years of directly related experience. in the pharmaceutical, biotechnology, CRO industry and/or related clinical trials environment;

OR

  • A M.S. degree in Biostatistics or related field with a minimum of 10 years’ directly related experience in the pharmaceutical, biotechnology, CRO industry and/or related clinical trials environment

Sr. Principal Biostatistician

  • A Ph.D. degree in Biostatistics or related field with a minimum of 5 years of directly related experience. in the pharmaceutical, biotechnology, CRO industry and/or related clinical trials environment;

OR

  • A M.S. degree in Biostatistics or related field with a minimum of 8 years’ directly related experience in the pharmaceutical, biotechnology, CRO industry and/or related clinical trials environment

Experience

  • Demonstrated experience in the application of statistical methodology in the planning, design, analysis and interpretation of clinical trial data with particular experience in the design and analysis of oncology studies
  • Demonstrated experience in using SAS and other relevant software for trial design, simulation and analysis
  • Prior experience influencing and leading teams

Knowledge, Skills and Abilities

  • Ability to provide sound statistical input to more independently influence strategic discussion and planning in clinical drug development
  • Strong statistical knowledge and technical skills as related to clinical trial designs, simulations, and analyses, particularly in oncology studies
  • Strong understanding of regulatory guidance on clinical trials, endpoints and issues, particularly in oncology area, and ability to more independently represent biostatistics in preparing regulatory documents and participating in regulatory interactions
  • Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
  • Must possess ability to handle multiple priorities in a fast-paced environment
  • Excellent oral and written communication skills
  • Demonstrated capability to effectively manage multiple tasks and projects with excellent attention to detail

Supervisory Responsibilities

No

Preferred Qualifications

  • Ph.D in statistics or related field, strong statistical knowledge and technical skills for trial design, simulation and analysis.
  • Biostatistics experience with oncology clinical trials

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