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Job: Head of Statistical Consulting

This posting has expired and is no longer available.

Job Description

Job Summary:

Provide leadership to help position the company at the forefront of the industry. Participate in the development of business and strategic plans to advance the company's mission and objectives and to promote revenue, profitability and growth as an organization. Interface with Executive Management staff to ensure that all goals and objectives are identified and met.

Primary Responsibilities:

  • Develop full Study Program strategies and Study Protocols from a Statistical Perspective, including endpoint determination, sample size calculation, analysis population definitions, and primary analysis strategies (primary model and missing data imputations strategies as well as sensitivity analyses), for new clients or new indications for existing clients and defending the statistical methodologies to regulatory bodies. 
  • Standardize Protocol section text for frequently captured and summarized measures (i.e. AEs, Demographics, Con Med, Med Hx, Disposition, Visual Acuity, IOP, Safety Labs, Vital Signs, etc) – to align with the standard table programming output.
  • Consult internally and externally on complex statistical strategies. As an example, be available to support lead statisticians for more complex model build and interpretation.
  • Maintain current understanding of regulatory initiatives/guidances impacting statistics – and develop standard strategies for addressing new such initiatives/guidances. For example, develop a standard strategy for multiple imputations for missing data assuming missing at random and missing not at random; developing standard code for continuous measures and discrete measures.
  • Complete/oversee the completion of one-off analyses for clients. This is for manuscript type of analyses for studies / data for which SDC did complete the production work, informal rescue type analyses for clients (like the pre-clinical sheep work you just completed).
  • Oversee the statistical analysis of research work requested by Ora (again, outside of standard clinical trial production work).

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.


Required Skills:

  • Experience in business and strategic planning and execution.
  • Knowledge of contracting, negotiating, and change management.
  • Skill in examining and re-engineering operations and procedures.
  • Experience in formulating policy, and developing and implementing new strategies and procedures.
  • Ability to develop financial plans and manage resources.
  • Ability to analyze and interpret financial data.
  • Knowledge of public relations principles and practices.
  • Ability to analyze performance data for trend analysis and continuous improvement opportunity.
  • Ability to develop and deliver presentations.
  • Ability to communicate effectively in writing and verbally at all levels of clients, suppliers, and employees.
  • Successful record of accomplishment in establishing, directing and overseeing statistical and data management operations division/department in a contract research organization (CRO) and/or pharmaceutical company
  • Working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
  • Skilled in analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills
  • Ability to identify operational inefficiencies and present and implement solutions
  • Good leadership, organizational and time management skills, with the ability to multi-task
  • Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
  • Strong interpersonal communication and presentation skills

Education or Equivalent Experience:

A PhD in Biostatistics or other related, scientific field and at least 8 years of relevant professional experience is mandatory.