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Will manage a small team of 6 members
Provide leadership and guidance as the statistical expert on a project team or within a therapeutic area. For one or more projects, be accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. Act as key statistical consultant within company. Responsible for project staffing, resource planning and allocation within therapeutic area(s). Responsible for facilitating career development of direct reports and assisting Department Head with creation and implementation of policies. May have regional or global management responsibility.
In some cases incumbent could serve as department leader in specific technical area.
•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
Major Duties and Responsibilities
1. 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 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.
2. 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 consistently compliant, in timing and quality, with SOPs and departmental standards.
3. 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 our company's standard data models, e.g. CIDSC.
4. 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 situation.
5. 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.
6. Maintain awareness of industry standards, regulatory requirements, and 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.
7. 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.
Major challenges involve design of statistical and operational approaches that will meet future regulatory needs. Key collaborators are external leaders and key staff in other disciplines. Specific challenges:
•Collaborating with key decision makers in other disciplines to develop successful strategic
•Establishing policies and working relationships with staff to ensure standards are met for quality, timeliness, and efficiency
•Producing plans and methodologies broadly acceptable to regulatory agencies and boards of health
•Remaining current on new developments in relevant statistical and clinical methodology, regulatory policy, and drug approvals
Key Internal & External Relationships
•Identify and maintain positive relationships with key external contractors / consultants; key project or therapeutic area leaders from other functional areas within company, including finance and human resources functions; opinion leaders, regulators, and key consultants; S-A global research management
Decision Making Authority
•Ensure procedures and practices within therapeutic area or project group are consistent with departmental SOP and relevant external standards
•Interpret the project implications of regulatory guidelines
•Review SAP and recommend approval
•Responsible for performance review and development of direct reports
•Take lead role in departmental initiatives
•Decision on resource requirement and allocation within TA
•Direct staff project and non-project assignments
•Identify and make decision on potential hires within therapeutic area or project group
MUST HAVE – NO EXCEPTIONS
PH.D. (MS) in statistics or related discipline with 10+ (12+) years of pharmaceutical experience, including significant interactions with regulatory bodies, history of successful management (4+ years), and expertise in one or more therapeutic areas (ANY)
•In-depth understanding of the regulatory drug submission / approval process regionally and globally
Experience managing direct reports, assembling teams, and implementing working relationships with external agencies, such as CRO, consultant groups, and research committees
•Knowledge of regulatory laws / procedures outside of US and Europe
•Leadership role in societies or committees relevant to drug development or statistics
•Ability to contribute to advancement of statistical or applied specialized area of knowledge
Can work from home 2 days a week.
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