Senior Manager, Statistical Programming

This is a fully remote position, open to applicants in United States.

📋 Description

• Ensure that all statistical elements related to clinical activities adhere to required standards and maintain statistical accuracy.

• Lead a team focused on Rare Disease and/or other therapeutic area products.

• Accountable for Global Statistical Programming study outcomes and submission activities within the designated product areas.

• Establish and advance programming strategies such as functional standards and industry requirements globally for the assigned product areas.

• Plan and oversee project progress while addressing issues as they arise.

• Support the GSP Functional Service Provider (FSP) relationship and oversight.

• Ensure that product goals are achievable through the FSP personnel.

• Contribute GSP product-level insights for developing and managing resource plans and budgets.

• Efficiently monitor and optimize the utilization of assigned staff at the product level based on priorities.

• Lead and/or engage in departmental process enhancement initiatives and cross-functional teams.

• Assist in conducting study and system audits and inspections by both internal and external entities.

• Develop, review, and implement Policies, SOPs, and other controlled documents impacting GSP on a global scale.

• Provide direct support to the assigned product areas as needed.

• Mentor and coach team members.

• Contribute to the career development plans of all staff involved in assigned projects.

⛳️ Requirements

• Doctorate degree with 2 years of statistical programming experience in the Pharmaceutical industry OR Master’s degree with 6 years of experience OR Bachelor’s degree with 8 years of experience OR Associate’s degree with 10 years of experience OR High school diploma/GED with 12 years of experience in statistical programming within the Pharmaceutical industry.

• Extensive knowledge of SAS Graph, SAS STAT, SAS Macro, and SQL.

• Advanced skills in SAS analysis and reporting.

• Prior experience in regulatory submissions.

• Comprehensive understanding and experience with data quality and compliance assessments.

• Familiarity with the software development life cycle (e.g., gathering user requirements, creating technical specifications, developing code, and formulating test plans).

• Knowledge of the R Programming language.

• Statistical programming experience within a clinical development context.

• Proven ability to work effectively in a globally distributed team with cross-cultural partners.

• Capability to lead and manage programmers to ensure the successful and timely execution of all programming activities for one or multiple studies from start to finish.

• Previous experience in staff development leadership and project management.

• Strong oral and written communication skills.

• Proficient in executing complex statistical programming and related tasks effectively.

🏝️ Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with substantial company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models, including remote and hybrid work arrangements, when feasible.