Biostatistics Manager

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Posted 4 weeks ago

Biostatistics Manager

Reports to: Head of Technical Services

Why you’re here

The Biostatistics (Biostats) Manager will have overall responsibility for the implementation and execution of biostatistical processes, guidelines and regulations for the successful planning, submission, execution, and reporting of clinical trials.

What you’ll deliver

  • Leadership and guidance as the statistical expert on a project team or within a therapeutic area
  • Accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity
  • Key statistical consultant within GreenLight Clinical and may have regional or global management responsibilities.
  • Assigned Line Management responsibilities and as such will be responsible for onboarding, project staffing, resource planning and allocation of their team within therapeutic area(s). They will facilitate career development of team members.

How we’ll measure it

  • Effective leadership for project teams and within therapeutic areas
  • Effective and efficient execution of statistical analyses and guidance for the data collection, production and presentation
  • Satisfactory support and guidance for project teams

What you’re responsible for

  • Oversee statistical support to multiple project teams. Collaborate with clinical and regulatory leads in defining general strategic approach, creating clinical development plans (CDP), and producing individual protocols. Work independently, or with other statistical departmental members or consultants, to develop effective statistical approaches applicable to the project.
  • Statistically valid CDP involving one or more studies designed to lead to a key decision point or submission. CDP, related protocols, and statistical analysis plans (SAP) consistent with overall project objectives. CDPs have degree of optimality in terms of timing, use of resources, and probability of success.
  • Oversee execution of statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries. Review and approve key results memos and statistical conclusions. Provide guidance to the clinical and regulatory teams regarding

conclusions and inferences from the data package. Ensure statistical representation at regulatory or other external meetings.

  • Completed data package relevant for submission or making key decisions. Statistical deliverables are consistently compliant, in timing and quality, with SOPs and departmental standards.
  • Provide general guidance on definition and documentation of key derived variables needed to support production of tables, listings, and graphs (TLG). Effect consistency of data collection and analysis across project or area.
  • Analysis datasets that are quality controlled, sufficient to produce TLG for reports, and consistent within projects. General compliance with GreenLight Clinical standard data models, e.g. CIDSC.
  • Plan and track project activities, timelines, and resource use across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity.
  • Accurate plans, well-managed projects, capacity to apply extra resources in urgent situations.
  • Ensure mentoring and development of staff. Encourage personal development in the context of project work. Learn and apply techniques to promote teamwork, quality, and motivation. Manage conflict.
  • Productive work environment, individual growth, development of strong contributors. Staff compliance with SOPs and departmental policies.
  • Maintain awareness of industry standards, regulatory requirements, departmental guidelines, and SOP. Within area of control, update procedures or practices as needed to remain in compliance.
  • Procedures and practices meet industry standards and are consistent with internal SOP.
  • Serve as departmental representative on division or corporate-wide teams. Advocate application of statistical thinking in decision-making. Work effectively with leaders in other functional areas.
  • Effective corporate use of statistical thinking. Efficient processes in clinical development and operations.

Qualifications

  • Degree or equivalent combination of education, training and relevant industry experience

Work experience

  • Pharmaceutical or CRO experience, including significant interactions with regulatory bodies, history of successful management, and expertise in one or more therapeutic areas
  • Demonstrated knowledge of general HR policies and management
  • Demonstrated leadership, project management, and interpersonal skills
  • Excellent verbal, writing, and presentation skills
  • Experience managing direct reports, assembling teams, and implementing working relationships with external agencies, such as CRO, consultant groups, and research committees
  • Ability to recruit, retain, motivate, and develop highly qualified persons; projects and reinforces corporate values
  • Broad knowledge and superior understanding of advanced statistical concepts and techniques
  • Innovatively applies technical principles, theories, and concepts 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 regionally and globally
  • Ability to effectively represent Biostatistics and Programming in multidisciplinary or cross-functional meetings
  • Ability to work in a fully self-directed manner

Technical knowledge & skills or other requirements

  • Strong time management skills including the ability to accurately scope and plan programming/technical activities and ability to multi-task to maintain demanding timelines.
  • Good understanding of project planning and management methods
  • Self-starter with ability to adapt and be flexible to changing priorities
  • Attention to detail and ability to work simultaneously on multiple priorities
  • Excellent communication, organizational and interpersonal skills
  • Collaborative and constructive team-member
  • Able to communicate technical concepts to non-technical cross-functional team members

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