Principal Statistical Programmer

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.

General Description:

The Principal Statistical Programmer, Statistical Programming is responsible for organizing a statistical programming group that supports multiple drug development programs. The role manages programmers who develop analysis datasets, produce tables and graphs, validate statistical programs, write general SAS application code, prepare electronic submission documentation, and explore new methodologies to improve statistical programming productivity.

Essential Functions of the Job:

• Collaborate with the Programming Product Lead and project leads on resource planning, allocation, and assignment of programmers; address resourcing to adequately staff projects, as needed.

• Contribute to departmental process and standards initiatives, including macro tools, innovation, and implementation of CDISC standards.

• Contribute to the development and implementation of the programming resource algorithm.

• Oversee internal and contract programmers; provide guidance and mentoring in statistical programming methodologies; and support career development for programmers on the team.

• Contribute to the selection and management of CROs, including strategic outsourcing providers, that conduct statistical programming.

• Oversee staff work supporting clinical trials, ad hoc analysis requests, and data validation in accordance with relevant statistical regulatory guidance and standards.

• Serve as a technical resource for the programming group and provide advice on complex programming tasks and standards.

• Provide managerial support to one or more employees, including leadership, training, and mentoring for effective performance.

• Participate in and support development of the therapeutic area user guide following CDISC industry standards.

• Represent Statistical Programming on cross-functional teams and in process improvement initiatives.

• Contribute to department culture building and engagement.

• Perform other duties as assigned.

Supervisory Responsibilities:

Manager role. Oversees internal and contract programmers, provides guidance and mentoring, supports career development, and provides managerial support to one or more employees, including leadership, training, and mentoring responsibilities.

Computer Skills and Other Qualifications:

• PC literacy and Microsoft Office skills, including Outlook, Word, Excel, and PowerPoint.

• Expert-level SAS programming, including developing original code and modifying existing code for complex programming assignments and analyses.

• Knowledge of SDTM and ADaM standards, including writing CDISC-standard dataset specifications and creating SDTM and ADaM datasets from specifications.

• Minimum 4+ years of clinical research and development programming experience using SAS.

• Experience leading teams supporting FDA, EMEA, and CDE filings.

• Solid knowledge and hands-on experience with CDISC standards, including CDASH, SDTM, and ADaM.

• Experience leading or working with centralized Statistical Programming teams.

• Experience developing and implementing statistical programming standards and procedures.

• Experience with the drug development process in preclinical, early, late-stage, and/or observational settings in related industries or academic research, including oncology trials.

• Fundamentals of project planning and management.

• Ability to adapt to changing priorities, maintain attention to detail, work under pressure, and take initiative on unfamiliar tasks.

• Ability to establish and articulate a team plan that ensures appropriate focus and direction.

• Accountability for individual and team performance, with judgment and decision-making that considers business impact and changing priorities.

• Excellent verbal and written communication skills and ability to collaborate effectively in a dynamic environment.

• Licenses or certifications: N/A.

• Travel: Not specified in the source job description.

Education Required:

Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or another relevant scientific subject, or equivalent related 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.

• 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.