Manager, Statistical Programming

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 Senior Manager, Statistical Programming is responsible for the organization of a statistical programming group 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:

• 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 internal and contract programmers, provide guidance, and mentoring to programmers in statistical programming methodologies. Responsible for career development of all programmers in 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 (For all Supervising Managers)
• 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:

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
• 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
• Fundamentals of project planning and management
• Drug development process

Communication & Interpersonal Skills:

• Excellent verbal and written 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.

Education:

• Master’s degree, in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject, or equivalent related experience

Experience:

• Minimum 7+ years’ clinical research and development programming experience using SAS

• 2+ years of demonstrated leadership experience

Licenses or Certifications:

N/A

• TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT (AS APPROPRIATE FOR THE POSITION)

• Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
• Ability to work on a computer for extended periods of time.
• Regularly required to sit for long periods of time, and occasionally stand and walk.
• Regularly required to use hands to operate computer and other office equipment.
• Close vision required for computer usage.
• Occasionally required to stoop, kneel, climb and lift up to 20 pounds.

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.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

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 BeOne Medicines 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.