• This position supports statistical programming activities for late stage drug/vaccine clinical development projects
• This may include leadership of one or more projects

Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support

• The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation
• The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables
• For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle
• Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices
• Maintain and manage a project plan including resource forecasting
• Coordinate the activities of a global programming team that includes outsource provider staff
• Membership on departmental strategic initiative teams
• Ability and interest to work across cultures and geographies
• Experience in process improvement

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• Effective interpersonal skills and ability to negotiate and collaborate effectively
• Effective written, oral, and presentation skills
• A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders
• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
• Designs and develops complex programming algorithms
• Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts
• Familiarity with clinical data management concepts
• Experience in CDISC and ADaM standards
• Experience ensuring process compliance and deliverable quality
• Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices
• Ability to anticipate stakeholder requirements
• Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
• US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables
• Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor
• Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
• Experience developing and managing a project plan using Microsoft Project or similar package

Active in professional societies

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment
• Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)

CDISC ADaM, Clinical Testing, Database Management Systems (DBMS), Data Management, Data Modeling, Numerical Analysis, Outcomes Research, Project Management, Project Planning, SAS Macros, Software Development, Stakeholder Relationship Management, Statistical Analysis Software (SAS), Statistical Programming, Waterfall Model

An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits

Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days