Senior Manager/Associate Director, Biostatistics - Oncology

Location
Tarrytown, New York
Salary
Competitive salary and benefits
Posted
May 17, 2018
Closes
Jul 14, 2018
Ref
10217BR
Career Fair Category
Career Fair

Senior Manager/Associate Director, Biostatistics - Oncology

Summary:

The Associate Director provides 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 protocols and submissions, including quality, relevance to regulatory perspective, and scientific validity. Responsible for facilitating career development of direct reports and assisting VP, BDM and/or Sr. Director, Biostatistics, with creation and implementation of policies. May have management responsibility. In some cases incumbent could serve as department leader in specific technical area.

Responsibilities:

• With minimal direction from departmental management, assume leadership role for providing statistical support to one or more project teams in the creation of a clinical development plan (CDP), study designs, and production of individual protocols. Work with other BDM members or consultants to develop effective statistical approaches applicable to project. Produce or review individual statistical analysis plan (SAP) and planned integrated summaries.

• Interact with the clinical / regulatory functions to define study endpoints and perform relevant sample size calculations. Learn key clinical and regulatory considerations, ensure that planned statistical methods are applicable, and communicate important statistical considerations to clients.

• Provide guidance, either personally or through a junior member of the statistical team, on definition and documentation of derived variables needed to produce planned TFL. Assume responsibility for accuracy of derived variables. Effect consistency of data collection and analysis within project.

• Oversee production of the statistical analyses according to SAP. Oversee preparation of the statistical methods and results sections for CSR and overall summaries. Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package. Serve as company statistical representative at regulatory or external meetings.

• Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization.

• Active research interest in area related to clinical trial. Advises all relevant employees about the procedures surrounding retention of data, records, and information for employees in their group. Participates in Regeneron task forces and cross-functional operational excellence initiatives.

Requirements:

Works in a changing and busy environment. Exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks. Works independently - self directed, high energy and strong work ethic. High degree of creativity, latitude and attention to detail required.

o Demonstrated strong leadership, project management, teamwork, and interpersonal skills

o Excellent verbal, written & presentation skills

o Broad knowledge and superior understanding of advanced statistical concepts and techniques

o Experience with application of technical principles, theories, and concepts to pharmaceutical clinical development and life cycle management

o Familiarity and experience with regulatory guidelines for drug development, submissions, and statistical practices

o Understanding of the drug submission and approval process regionally and globally

o Proven ability to effectively represent Biostatistics and Data Management in multidisciplinary meetings

o Experience managing direct reports, contractors, teams, and external agencies, such as CROs, consultant groups, and research committees

o Proven ability to inspire and empower others

o Sought out for advice by others at senior levels

o Ability to work independently

o SAS, S-Plus/R, Sample size calculation software (e.g., EaSt and Nquery)

o Also Acceptable - Ph.D. in statistics or related discipline with 10+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interactions with regulatory bodies, history of successful management (2+ years), and expertise in one or more therapeutic areas

o May report to a Sr. Director or above. Requires the ability to influence others to achieve results. May manage subordinate supervisors.