BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 2,200 employees in China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, please visit www.beigene.com.
The Senior Director / Director, Statistical Programming will be responsible for the organization and long-term strategic leadership of a statistical programming unit / therapeutic area that supports multiple drug development programs The incumbent will manage a group of programmers who develop statistical programs that generate analysis datasets, produce outputs for tables and graphs, validate statistical programs, write general SAS application codes, prepare documentation for electronic submissions, and explore new methodologies to improve productivity of statistical programming.
Essential Duties & Responsibilities
Collaborates with lead project Biostatisticians in the creation, implementation, and maintenance of programming development plans for each project accounting for timelines, resources, and quality deliverables for all project work assigned; ensure that all programming has been carried out per industry and internal standard practice.
Collaborate with Data Management to implement the CDISC standard at the CRF and database build-up stage.
Supports overseeing the projects for the creation of analysis datasets, production/validation of output, and review of annotated case report forms
Manage the statistical programming support of FDA/EMEA regulatory submissions follow CDISC standards
Contributes to departmental process and standards initiatives such as CDISC.
Oversees the work of internal and contract programmers, will provide guidance, and mentoring to programmers in statistical programming methodologies. The Director of statistical programming will be responsible for career development of junior programmers.
Leads the selection and management of CROs (including the strategic outsourcing providers) conducting statistical programming.
Oversee the work of staff in support of clinical trials, ad-hoc analysis requests, data validation, etc. in accordance with all relevant statistical regulatory guidance and standards. Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance (For all Supervising Managers)
Lead or participant the development of TAUG (therapeutic area users guide) following CDISC Industry standards
Other duties as assigned
Core Competencies, Knowledge and Skill Requirements
Communication & Interpersonal Skills
Excellent verbal and written communication skills
Ability to effectively collaborate in a dynamic environment
Interacts with employees at all levels
Experience leading teams supporting NDA and EMEA filings.
Flexible to changing priorities, detail-oriented, works well under pressure with initiative to take on unfamiliar tasks.
Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction.
Demonstrated ability to accept responsibility for individual and team performance (accountability & ownership).
Demonstrated ability to evaluate the business impact of decisions and remains committed to following through on agreed upon decisions yet remains flexible should priorities change (judgment and decision making).
Experience in development and implementation of statistical programming standards and procedures is required.
Experience using industry standards such as CDASH, SDTM, and ADaM.
Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS SQL; SAS/GRAPH a plus. Experience using SAS version 8 or higher.
Proficient in developing their own code as well as modifying existing code.
Adaptability Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
BeiGene Is An Equal Opportunity Employer
BeiGene is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristics protected by law. As a federal contractor, BeiGene has established affirmative action programs to ensure non-discrimination and affirmative action in BeiGene's policies and practices for qualified women, minorities, protected veterans, and individuals with disabilities. The narrative portions of BeiGene's affirmative action plans for individuals with disabilities and veterans are available for inspection at our offices during normal business hours. Employees and applicants interested in inspecting these plans should contact our Human Resources department by email at firstname.lastname@example.org for assistance.