Director, Statistical Programming

This Is What You Will Do

• Serve as the Lead Programmer and Manager of the statistical programming efforts for a compound / indication.
• Develop and validate technical programming specifications for analysis datasets using Alexion or ADaM standards.
• Independently develop and validate programs that generate analysis datasets based on Alexion or ADaM specifications.
• Develop and validate technical programming specifications for protocol specific efficacy tables, listings, figures/graphs.
• Independently develop and validate programs that generate protocol specific efficacy tables, listings, figures/graphs using Alexion specifications.
• Ensure that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.
• Provide secondary reviews of Statistical Programming deliverables.
• Directly support the Statistical Programming Sr. Director in all aspects of the management and development of the Statistical Programming team.
• Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary.
• Create and/or review programming plans and ensure appropriate resource allocation and prioritization.
• Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.
• Manage adherence to all company policies, SOPs, and other controlled documents; and ensure all programming activities adhere to departmental standards.
• Assume direct line management responsibility of the statistical programmers, conducting performance reviews, setting and regularly reviewing objectives, providing guidance and mentoring, and developing and regularly reviewing training and career development plans.
• Plan and manage department budget. Forecast quarter, annual, and 3-5 year budget.
• Participate in strategic development meetings across departments.
• Evaluate, develop, revise, implement and ensure compliance to functional guidelines, policies, and SOPs.
• Collaborate across all functional areas to ensure programming needs are met with specific regards to study data specifications, applications and computing environment support.
• Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support.
• Collaborate closely with Preferred Vendor management in terms of governance, recruiting needs, contract development and signature, and any other partnership requirement that may arise.

You Will Be Responsible For

• Ensuring that the filing of study documentation is maintained to the standard required according to processes and acceptable for audit.
• Provide secondary reviews of Statistical Programming deliverables.
• Directly support the Statistical Programming Sr. Director in all aspects of the management and development of the Statistical Programming team.
• Participate in the ongoing review of the processes used by the Statistical Programming group to ensure processes are continually complied with and updated as necessary.
• Create and/or review programming plans and ensure appropriate resource allocation and prioritization.
• Act as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.
• Manage adherence to all company policies, SOPs, and other controlled documents; and ensure all programming activities adhere to departmental standards.
• Assume direct line management responsibility of the statistical programmers, conducting performance reviews, setting and regularly reviewing objectives, providing guidance and mentoring, and developing and regularly reviewing training and career development plans.
• Plan and manage department budget. Forecast quarter, annual, and 3-5 year budget.
• Participate in strategic development meetings across departments.
• Evaluate, develop, revise, implement and ensure compliance to functional guidelines, policies, and SOPs.
• Collaborate across all functional areas to ensure programming needs are met with specific regards to study data specifications, applications and computing environment support.
• Collaborate closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support.
• Collaborate closely with Preferred Vendor management in terms of governance, recruiting needs, contract development and signature, and any other partnership requirement that may arise.

Qualifications

• 10+ years statistical programming experience in the CRO or Pharmaceutical Industry.
• 7+ years people and / or project management experience in the CRO or Pharmaceutical Industry.
• Advanced SAS programming skills in a clinical and statistical data environment across multiple therapeutic areas.
• Thorough understanding of relational databases and their correlation to submission ready database structure.
• Strong project management skills and experience with scope management, resource management, financial management, project planning and resource allocation.
• Significant experience in a leadership capacity with a focus on identifying, leading and advancing talent.
• Experience working in a clinical development organization with a heavy emphasis on support of multiple, ongoing projects.
• Thorough understanding of pharmaceutical clinical development (i.e. understanding of statistical concepts, techniques, and clinical trial principles) and ability to manage and lead regulatory submissions.
• Thorough understanding of industry standards such as CDISC and 21CFR Part 11.
• Strong ability to solve problems, recommend process improvements, and execute on process improvements.
• Ability to lead and influence teams.
• Excellent verbal and written communication skills in a global environment.
• Proven ability to work with cross functional teams, specifically Data Management, Biostatistics, Epidemiology, Clinical Operations, and Pharmacovigilance to initiate, lead and execute new initiatives and process improvements.
• Recognize behaviors that align with our values critical to the success of our employees, mission, and business objectives.
• BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.

Pay

The annual base pay (or hourly rate of compensation) for this position ranges from $165,095.20 - $247,642.80. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.