Celgene Corporation Berkeley Heights , NJ 07922
Associate Director, Statistics
Req #: 1802933
Location: Berkeley Heights, NJUS
Job Category: Clinical Operations
Work Location: 300 Connell Dr BERKELEY-300 7922
Organization: Celgene Corporation
Employee Status: Full time
Job Type: Regular
Other Locations:US- NJ- Berkeley Heights- 300
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.
Ph.D. in Statistics with 8+ years (or 10+ years for MS) pharmaceutical experience as a statistician supporting clinical trials.
Responsibilities will include, but are not limited to, the following:
Actively provide statistical support to Celgene Research and Development
Serves as the global lead statistician in the support of trial Phases I-III of drug development for a therapeutic area
Manages multiple studies within an indication or therapeutic area.
Serves as an advisor to statisticians assigned to the project to ensure high quality and timely deliverables
Guides global staff in the preparation of Statistical Analysis Plans. Shepherds the plan through clinical review to ensure worldwide organizational acceptance of the statistical design, endpoints, and proposed analyses
Ensures consistency and adherence to standards within a projec
Contributes to Clinical Development Plans, submissions and post-submission strategies, preparations and defense, ensuring quality and timing thereof
Provides statistical support for Health Authority requests, publications, presentations, and posters at medical conferences/symposia, as assigned
Contributes to, and provides training on new departmental statistical topics, SOPs, WPs
Impacts directly on overall business and Biostatistics performance through the ability to influence and work in a consultative manner with senior stakeholders
Sets project level priorities
Manages resources to meet project team timelines.
Escalates issues to functional management as necessary
Makes recommendations or resolves technical, quality, and timeline issues
Manages outside CROs and contractors
Recommends external statistical experts for consultation
Provides guidance to employee's development plan and carries out performance review and feedback
Evaluates the effectiveness of Biostatistics programs, policies, and processes to meet evolving stakeholder needs
Leverages best practices in Biostatistics management to enhance efficiencies
Provides directions to project teams using statistical expertise and project knowledge
Manages team conflicts to resolution and improved team collaboration
Maintains close collaboration and working relationships with stakeholders
Manages conflicts with external partners/customers.
Represents Biostatistics function at cross-functional meetings
Oversees/coordinates biostatistical activities on global submission teams.
Partners with senior line management to shape Biostatistics strategy in alignment with the business strategy
Works closely with stakeholder leaders to develop and implement high impact business initiatives
Leverages existing Biostatistics programs, policies, and procedures to create value-added solutions for Biostatistics
Provides proactive expertise, coaching, and counseling to stakeholder leaders, employees, and peers on complex Biostatistics and stakeholder issues
Sought out thought leader, providing coaching and mentoring to peers, Statisticians/Programming team members and others
Provides continuous feedback to peers and leaders
Proactively seeks ways to gain broader experience/perspectives and focuses on a robust professional development plan
Leads cross-functional collaboration and conducts meetings to gain the trust and respect of members, make decisions on business issues and freely challenges and expresses opinions may manage and or develop staff; provide coaching and mentoring, monitors other's performance, makes recommendations on resource allocations and provides feedback via formal/informal appraisals
Ph.D. or MS in statistics (or related field) with a focus on statistical methods appropriate for clinical trials.
Experience in clinical drug development: 8+ years for Ph.D., 10+ years for MS. Experience in the relevant therapeutic areas is preferred.
Demonstrated skill in the planning, analysis and reporting of clinical trials.
Detailed knowledge of statistical methodologies, relevant therapeutic areas, and statistical regulatory requirements.
Previous experience in leading and completing a task force or supervising statisticians
Abreast of clinical trial design concepts.
In-depth knowledge of all phases of the drug development process
Demonstrated ability to work in a team environment with clinical team members.
Good interpersonal, communication, writing and organizational skills
Abreast of statistical method development and able to decide on the optimal methods acceptable to regulatory agencies
Abreast of relevant project area's clinical trial development and regulatory requirements.
Establishes performance standards and commits to evaluation and review of developmental opportunities.
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.