Director, Statistical Programming
1 month ago
This is what you will do:
The Director of Statistical Programming will be primarily responsible for leading all aspects of statistical programming activities for multiple clinical studies within multiple Therapeutic Areas, maintaining programming infrastructure and ensuring compliance with SOPs to produce quality and timely deliverables. They must possess extensive experience and proven skills in the use of SAS within a Statistical Programming environment and complete knowledge and understanding of the statistical programming processes, procedures, and roles. They will use knowledge of CDISC SDTM and ADaM standards to support Biostatistics in statistical analysis, including generating analysis data listing, tables, and figures and create all files necessary to support an electronic submission in the eCTD format. Additionally, the successful candidate will use their strong people management skills and supervisory skills to provide direct line management to statistical programmers and external partners, identify training needs and opportunities for optimizing staff utilization and employing the most efficient practices. They should be able to identify project resource requirement needs and manage large external provider contract budgets. They will be responsible for the direct-line management of the statistical programmers through Associate Director level staff.
You will be responsible for:
- Serve as the Lead Programmer and Manager of the statistical programming efforts.
- 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.
- 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. Responsibilities will include, but are not limited to:
- 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 need to have:
- A minimum of 10 years of Biostatistics/SAS programming experience, including at least 3 years managing direct reports.
- 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.
We would prefer for you to have:
- BS/MS/MA in Statistics, Biostatistics, Computer Science, Mathematics or related area.
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