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BeiGene is seeking an Associate Director of Statistical Programming to lead a team in developing statistical programs for drug development. The role involves managing resources, collaborating across functions, and enhancing programming methodologies. Ideal candidates will have a strong background in oncology and statistical programming, and proven leadership experience.
BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Position Summary:
The Associate Director, Statistical Programming is responsible for leading a statistical programming team who supports multiple drug development programs. The incumbent will manage a group of programmers who develop statistical programs who 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:
Collaborate with Programming Product Lead and Project Leads in the resource planning, allocation and assignment of programmers. Address resourcing to adequately staff projects as needed.
Lead or contribute to departmental process and standards initiatives such as macro tools, innovation, CDISC standards implementation.
Contribute to the development and implementation of programming resource algorithm.
Oversee the work of both internal employees and contract programmers, provide guidance, and mentoring to programmers in statistical programming methodologies. Responsible for career development and performance management of all programmers on the team.
Contribute to 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.
Be a technical resource for programming group to provide advice on complex programming tasks and/or standards.
Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance
Participate and support the development of TAUG (therapeutic area users guide) following CDISC Industry standards
Represent statistical programming in cross-functional teams and process improvement initiatives.
Contribute to department culture building and engagement
Other duties as assigned
Core Competencies, Knowledge and Skill Requirements:
Knowledge of SDTM and ADaM standards, able to write CDISC standard dataset specifications and follow specifications to create SDTM and ADaM datasets (as needed)
Computer programming using SAS
PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)
Fundamentals of project planning and management
Extensive experience in the Oncology drug development process within a sponsor-side pharmaceutical or biotech organization.
Communication & Interpersonal Skills:
Excellent verbal and written English communication skills
Ability to effectively collaborate in a dynamic environment
DESIRED BACKGROUND AND EXPERIENCE
Experience leading teams supporting FDA/EMEA/CDE filings.
Solid knowledge and hands-on experience of CDISC standards such as CDASH, SDTM, and ADaM
Experience leading or working with centralized teams for Statistical Programming
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
Experience with the drug development process (pre-, early, late and/or observational) in related industries or academic research. Experience with oncology trials.
Expert level SAS programmer with experience in delivering complex programming assignments and analysis. Proficient in developing their own code as well as modifying existing code.
Excellent working knowledge of Base SAS, SAS/STAT, SAS Macro language and SAS SQL; SAS/GRAPH a plus. Experience with R/Spotfire/Python a plus.
REQUIREMENTS
Education:
Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject, or equivalent related experience
Experience:
6+ years’ of directly related experience in biometrics (along with a M.S.). 8+ years with a Bachelor’s, and 4+ with a PhD. Relevant experience working within a sponsor pharmaceutical or biotech organization is required.
4+ years of demonstrated people management and team leadership experience.
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene, Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.