Senior Scientist, Statistical Programming, Late-Stage Oncology

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Assist in statistical programming tasks for advanced drug and vaccine clinical development initiatives.

• Take the lead on one or more projects.

• Create and implement statistical analysis and reporting outputs, which include datasets for safety and efficacy analyses, as well as tables, listings, and figures.

• Support clinical trials with global regulatory application submissions and post-marketing efforts.

• Design and oversee statistical datasets for clinical development, outcomes research, and safety evaluation stakeholders.

• Collaborate with statistics and project stakeholders to effectively execute plans and deliver high-quality results punctually.

• Act as the main point of contact for statistical programming and a knowledge resource throughout the product lifecycle.

• Develop and verify analysis and report programming in accordance with global and therapeutic-area standards, departmental SOPs, and sound programming practices.

• Manage and oversee project plans, including resource forecasting.

• Coordinate a global programming team, including outsourced provider personnel.

• Engage in departmental strategic initiative teams.

• Ensure that programming deliverables uphold data integrity and quality after database lock (DBL), including unblinded data.

• Tackle emerging post-DBL challenges through effective stakeholder communication and technical resolution.

⛳️ Requirements

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, or a related discipline, with a minimum of 5 years of SAS programming experience within a clinical trial context, OR an MS in one of these fields with at least 3 years of relevant experience.

• Strong interpersonal, negotiation, collaboration, written, verbal, and presentation abilities.

• Knowledge and experience in developing analysis and reporting outputs for R&D projects, including data, analyses, tables, graphics, and listings.

• Capability to lead projects and independently complete tasks at the project level.

• Extensive expertise in SAS and clinical trial programming, encompassing DATA steps, procedures, SAS/MACRO, and SAS/GRAPH.

• Proficiency in systems and database management.

• Ability to design and create complex programming algorithms.

• Proficient in understanding analysis plans and statistical terminology and concepts.

• Familiarity with clinical data management principles.

• Experience with CDISC and ADaM standards.

• Background in ensuring process compliance and maintaining deliverable quality.

• Strategic mindset with the ability to transform strategy into actionable tasks.

• Capable of designing statistical databases that enhance analysis and reporting while employing standards and best practices.

• Ability to anticipate stakeholder needs.

• Proven proficiency in guiding statistical programming deliverables post-DBL, ensuring complete data integrity of unblinded data.

• Strong ability to perform effectively in high-pressure situations and resolve emerging post-DBL challenges.

• Preferred: expertise in advanced programming languages like R, including Shiny, and/or Python.

• Preferred: knowledge of Generative AI and new technologies in statistical programming workflows.

• Preferred: experience in regulatory application submissions for US and/or global drug or vaccine products.

• Preferred: experience with project-planning software such as Microsoft Project.

• Preferred: involvement in professional society activities and process improvement initiatives.

• Ability and willingness to work across diverse cultures and regions.

• Competency in completing deliverables using global outsourced programming teams.

• Visa sponsorship is available.

• A valid driving license is not required.

🏝️ Benefits

• Eligibility for annual bonuses.

• Long-term incentive eligibility, if applicable.

• Medical healthcare coverage.

• Dental healthcare coverage.

• Vision healthcare coverage.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate leave.

• Sick leave.