Senior Director, Statistical Programming
Descrizione dell'offerta
Senior Director, Statistical Programming
Scope of the Role
As Senior Director of Statistical Programming, you will lead the statistical programming team, overseeing resource management, project delivery, and process efficiencies. You will ensure that the team’s activities align with business priorities, provide technical expertise to develop programming standards and procedures, and maintain a high-performing, compliant, and collaborative environment across global functions. This role requires close interaction with cross-functional teams including Biostatistics, Data Management, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and Commercial, as well as vendors and CROs.
Your Role
- Lead and manage the statistical programming team to ensure optimal use of resources, adherence to timelines, and achievement of departmental and organizational goals.
- Ensure infrastructure, staffing, and training plans support project completion on time and within budget.
- Provide accurate forecasting for annual budgets and manage financial performance throughout the year.
- Mentor, coach, and develop team members to maximize performance and career growth.
- Maintain complete and auditable documentation of all programming activities and oversee CRO/vendor deliverables.
- Provide statistical programming support for regulatory submissions, exploratory analyses, and ad‑hoc requests.
- Manage development, testing, and documentation of global utility programs and tools per standards and validation procedures.
- Participate in creation, implementation, and maintenance of departmental procedures and standards.
- Facilitate communication and collaboration across cross‑functional teams and ensure alignment with legal, compliance, and regulatory requirements.
- Champion the “ONE Team” approach to foster collaboration and focus on patient and customer priorities.
- Maintain a positive, results‑oriented work environment, modeling teamwork, open communication, and corporate values.
Who You Are
- 15+ years of experience in statistical programming within Biotechnology, Pharmaceutical, or CRO environments, including 5+ years in a leadership role.
- Prior experience managing a statistical programming team is required.
- Expert in Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, SAS/ODS, and R.
- Deep understanding of ICH guidelines, CDISC standards, 21 CFR Part 11, FDA and EMA regulations, and global drug development processes.
- Experience with eCTD NDA submissions.
- Bachelor’s degree in Statistics, Mathematics, Computer Science, or related field; Master’s preferred.
- Exceptional organizational, multi‑tasking, and problem‑solving skills; able to prioritize and work strategically across a matrix organization.
- Strong interpersonal and communication skills to collaborate effectively at all levels.
- Demonstrates leadership by fostering collaboration, excellence, innovation, integrity, passion, and patient/stakeholder centricity.
- Ability to work independently and collaboratively, adapt to change, and drive process improvements.
Why Join Alfasigma:
At Alfasigma, we foster a culture where the courage to innovate is key to our success.
We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.
Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open‑mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.
Join Alfasigma and become part of a forward‑thinking team dedicated to shaping the future of the pharmaceutical industry.
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