Sironax is seeking a highly motivated and experienced Associate Director, Statistical Programming to play a critical leadership role within our global clinical development organization. This position combines strategic oversight with hands‑on programming expertise, offering a unique opportunity to influence clinical development, regulatory submissions, and corporate milestones.
The ideal candidate is adaptable, collaborative, and thrives in a fast‑paced biotech environment. You will oversee CRO programming deliverables while also supporting high‑priority internal analyses, executive presentations, and regulatory reporting activities across multiple therapeutic areas, including rare diseases.
Key Responsibilities
- Lead oversight and management of CROs and external vendors to ensure timely, high‑quality delivery of SDTM, ADaM, and TFL outputs.
- Provide hands‑on statistical programming support for internal analyses, executive presentations, investor materials, and regulatory submissions.
- Collaborate closely with cross‑functional teams including Biostatistics, Clinical Operations, Data Management, Regulatory Affairs, and Investor Relations.
- Maintain alignment across global teams, including effective collaboration with US‑and China‑based stakeholders across multiple time zones.
- Ensure compliance with CDISC standards, FDA/EMA regulatory requirements, and industry best practices.
- Support programming activities across a diverse clinical pipeline, including complex and data‑limited rare disease programs.
- Contribute to process improvement initiatives, programming standards, and operational efficiencies within the statistical programming function.
Qualifications
- Bachelor’s or Master’s degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related quantitative discipline.
- Minimum of 8 years of statistical programming experience within the biotechnology or pharmaceutical industry.
- At least 2 years of leadership, vendor oversight, or project management experience.
- Advanced proficiency in SAS programming; experience with R programming is highly desirable.
- Strong knowledge of CDISC standards (SDTM and ADaM) and regulatory submission requirements.
- Experience supporting regulatory submissions and corporate milestones such as investor presentations or fundraising activities is preferred.
- Excellent communication and collaboration skills with the ability to work effectively in a global environment.
Equal Opportunity Employer
Sironax is an equal opportunity employer committed to diversity, equity, and inclusion. We welcome applicants from all backgrounds and are dedicated to creating a work environment where everyone feels valued and empowered.
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