Senior Director, Biostatistics (6 Month Remote Contract)

Precision Life Sciences - Raleigh, NC

Our client is seeking a Senior Director, Biostatistics for a 6-month remote contract. The Senior Director, Biostatistics is responsible for the successful operation of the Biostatistics department, overseeing the statistical aspects of projects and project teams through the management of department managers, internal staff, and interaction with Executive-level staff. They oversee the maintenance of optimal department processes, the implementation of project-specific strategies, and the development and implementation of department strategies to increase productivity and quality. The Senior Director, Biostatistics works closely with the head of Statistical Programming to coordinate all statistical and programming activities of client projects.

Primary Duties + Responsibility:

  • Responsible for the direct management of Biostatistics Management and indirect management of all Biostatistics staff, including hiring, resourcing, personnel development, growth, training, employee relations, and leading department meetings
  • Responsible for providing strategic direction and leadership to the Biostatistics team to best achieve departmental and company goals. In conjunction, s/he also participates as a member of the Senior Leadership Team
  • Interacts with clients to provide a high standard of customer service and ensure a complete understanding of Biostatistics capabilities
  • Interacts with Strategic Consulting, Regulatory Affairs, and Project Management teams to provide a high standard of consultation on issues related to the design, analysis, and interpretation of clinical trials in a variety of therapeutic areas
  • Attend meetings with scientific advisory groups and regulatory bodies, as needed, to support statistical aspects of regulatory submissions on behalf of sponsors
  • Serve as a thought leader by staying abreast of the latest developments in the field of statistics in drug development; maintain and improve professional knowledge of technological advancements in data manipulation and statistical analyses; promote and communicate statistical awareness and the role of the department internally at the company (e.g. training, seminars) and externally (e.g. conferences, training); Participate in external events to elevate industry presence
  • Plan, coordinate, and provide statistical analyses, summaries, and reports of studies in the support of product development including IND/NDA and BLA submissions, and IDE and PMA submissions
  • Participate in business development activities, including proposal generation, presentations of capabilities, and bid defenses
  • Participate in governance meetings with Sponsors, and establish relationships with Sponsor peers
  • Ultimately accountable for department financials (profit and loss), including participation in corporate revenue recognition activities and senior leadership meetings related to Biostatistics and Programming (along with the head of Programming)
  • Oversee corporate compliance activities as it relates to Biostatistics, including development and review of department policies, SOPs, and other controlled documents, as well as participation in client audits
  • Oversee departmental project responsibilities are completed in an accurate and timely manner, consistent client SOPs and with high quality, through management of staff
  • Serve as a champion of continuous process improvement within the department, to bring efficiencies and best practices to the organization through the design and implementation of new or updated procedures or workflows.
  • Collaborate with all other department functional heads as it relates to project work and company-wide initiatives
  • Leads by example and models core values in all actions; ensure a positive, respectful team environment, fostering collaboration and development

Experience & Minimum Requirements

  • Ph.D. or Masters in Statistics, Biostatistics, math-related discipline, or related field, with applied statistics training relevant to clinical trials or health research, with 10 years of relevant work experience, with a minimum of 5 years of supervisory experience, preferably in a CRO environment
  • Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research
  • Demonstrated ability to thoughtfully solve problems, exercise sound judgment, lead by example, and influence without authority
  • Demonstrated ability to think “big picture” and strategically leverage expertise, to serve as a consultant and business partner with internal and external customers
  • Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials are required
  • Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical/biotech companies
  • Skilled in the use of computer technology, including SAS and other statistical applications, and ability to learn new applications

 



Posted On: Monday, November 21, 2022



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