Celgene Executive Director, Global BioStatistics in Berkeley Heights, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Responsibilities will include, but are not limited to, the following:
Reporting to the CVP of BioStatistics and Data Management, this individual will lead the Biostatistics function within Celgene Corporation with responsibility across the entire lifecycle of research, development and commercialization for all compounds. The individual will be responsible for global strategy as well as design and implementation of the biostatistics responsibilities, contributing to and translating the research, development and commercialization strategies into tactical plans to support product development objectives in a rapidly growing, global organization. The successful candidate will provide expertise and guidance in collaboration with other groups broadly across the organization in clinical study design and reporting, and will institute best practices with regard to planning, execution, and interpretation of clinical projects and studies that span the disciplines of research, clinical development, clinical pharmacology, medical affairs, drug safety as well as market access and post marketing initiatives. He/she will facilitate an environment of data driven decision making across Celgene and will serve as a key member of the BDOMWSP leadership team in shaping its vision and future direction.
This individual will establish, maintain and refine the standards for information systems used within the biostatistics area including company policy, practices and operating procedures in compliance with industry standards.
In addition, this individual will:
• Set strategic direction for Biostatistics and ensure capabilities are in place to support the strategy
• Lead the Biostatistics organization by recruiting, retaining, developing and inspiring top talent
• Own responsibility for supervision of all statistical personnel involved in the preparation of clinical summaries and supporting data for regulatory submissions, publications, and presentations. This includes design of protocols, preparation of statistical analysis plans, statistical analyses, clinical study reports, and regulatory submissions.
• Drive evaluation, acquisition, development and maintenance of systems (computer and processes) to support biostatistics operations.
• Ensure appropriate department representation on clinical teams
• Maintain appropriate documentation for systems, together with appropriate SOPs for the statistical procedures
• Budget development and resource tracking
• Develop and expand effective collaborative relationships with all stakeholders
• Ensure quality and compliance of consultants with regard to processes, SOPs, and global templates
• Oversee support for biostatistics activities outsourced to CROs and independent contractors
• Ensure documents produced by vendor are produced according to approved SOPs and regulatory guidelines
• Keep abreast of regulatory and scientific issues through close contact with Regulatory Affairs members and by attending training sessions and workshops on relevant topics. Keep Senior Management informed of associated activities.
• Master’s Degree / Ph.D. in statistics or biostatistics, with focus on statistical methods appropriate for clinical trials. Ph.D. preferred
• Strong experience in leading and growing a statistics organization responsible for support of Early Development, Translational Medicine and Biomarkers.
• Experience with Oncology clinical trials required, experience with Immunology, Inflammation and Neuroscience clinical trials a plus
• Knowledge about state of the art technologies and processes including related to electronic submissions
• Prior experience and record of accomplishment leading global teams
• Prior contributions to cross functional project teams, including determining resourcing needed for current activities and provide projections for future activities
• Skill in performance management including objective setting, appraisals and staff development, within Biostatistics
• Broad understanding of statistical methods that apply to all phases of clinical trials, including the ability to technically address unique statistical challenges
• A demonstrated commitment to continuous learning
• Experience in providing biostatistics support for marketed products/indications and for compounds/indications in early development
• Experience communicating with and presenting to the U.S (FDA) and European Regulatory authorities (EMEA), Japanese (PMDA) and other health authorities as the biostatistics representative associated with filings and/or clinical trials
• Working knowledge of all relevant statistical regulatory guidances and standards (e.g., FDA, ICH, EMEA)
• Prior experience in successfully implementing, utilizing and leveraging outsourcing strategies
• Has held direct responsibility for the statistical portions of NDAs, including follow-up support during the approval process
• Knowledge of a wide variety of statistical and programming techniques and statistical and graphics software, and standard word processing and spreadsheet programs
• Ability to work cooperatively in a team environment and communicate throughout the organization within a fast-paced cross functional environment while prioritizing multiple competing tasks and demands
• Ability to manage staff and oversee vendors as required
• Ability to evaluate and implement new technologies and processes
• Excellent interpersonal, communication, writing and organizational skills
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Executive Director, Global BioStatistics
Location: Berkeley Heights, NJ, US
Job ID: 17001041