Director, Statistical Programming

The Director of Statistical Programming will oversee statistical programming activities for multiple clinical studies across various Therapeutic Areas. This role involves maintaining programming infrastructure, ensuring compliance with SOPs, and producing quality and timely deliverables. The ideal candidate will have extensive experience with SAS in a Statistical Programming environment and a thorough understanding of statistical programming processes and CDISC SDTM and ADaM standards. This role also requires strong people management skills to provide direct line management to statistical programmers and external partners, identify training needs, and manage large external provider contract budgets.

Accountabilities

- Serving as the Lead Programmer and Manager of the statistical programming efforts for a compound/indication.

- Developing and validating technical programming specifications for analysis datasets using Alexion or ADaM standards.

- Independently developing and validating programs that generate analysis datasets based on Alexion or ADaM specifications.

- Developing and validating technical programming specifications for protocol-specific efficacy tables, listings, figures/graphs.

- Independently developing and validating programs that generate protocol-specific efficacy tables, listings, figures/graphs using Alexion specifications.

- Ensuring that the filing of study documentation is maintained to the required standard according to processes and acceptable for audit.

- Providing secondary reviews deliverables.

- Directly supporting Sr. Director in all aspects of the management and development team.

- Participating in the ongoing review of the processes used by the group to ensure processes are continually complied with and updated as necessary.

- Creating and/or reviewing programming plans and ensuring appropriate resource allocation and prioritization.

- Acting as the primary department contact, when necessary, to ensure that department standards are implemented in all studies.

- Managing adherence to all company policies, SOPs, and other controlled documents; ensuring all programming activities adhere to departmental standards.

- Assuming direct line management responsibility of the statistical programmers, conducting performance reviews, setting and reviewing objectives, providing guidance and mentoring, and developing and regularly reviewing training and career development plans.

- Planning and managing department budget. Forecasting quarter, annual, and 3-5 year budget. Participating in strategic development meetings across departments.

- Evaluating, developing, revising, implementing, and ensuring compliance with functional guidelines, policies, and SOPs.

- Collaborating across all functional areas to ensure programming needs are met with specific regards to study data specifications, applications, and computing environment support.

- Collaborating closely with Biostatistics, Clinical Data Management, Pharmacovigilance, Clinical Operations, and other functions within Alexion to address their needs for programming support.

- Collaborating closely with Preferred Vendor management in terms of governance, recruiting needs, contract development and signature, and any other partnership requirement that may arise.

- Any other activities as required.

You will need to have:
- 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.
- Detailed 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.
- Skilled in resolving issues, suggesting process improvements, and effectively completing them.
- 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 implement 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.
- Competencies:
  - Accountability
  - Collaboration
  - Decision Quality
  - Drive for Results
  - Perseverance
  - Problem Solving
  - Informing
  - Peer Relationships
  - Time Management
  - Building Effective Teams
  - Managing Through Systems

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Joining Alexion means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave pioneering spirit – we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the entrepreneurial spirit of a leading biotech while meeting the needs of some of the most under-served patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient's journeys. You’re supported by exceptional leaders ready to lift you in marketing, compliance, and beyond.

Ready to make an impact? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.