Associate Director, Statistical Programming

Sironax; Waltham (MA); On-site; USD 130,000 - 160,000; Full time

Job summary

Sironax is looking for an Associate Director, Statistical Programming to lead programming efforts and manage CRO deliverables within the clinical development team. This role plays a pivotal part in influencing regulatory submissions and company milestones, while providing hands-on statistical programming support.

The position requires expertise in SAS and a strong background in statistics or biostatistics, with a minimum of 8 years of experience in the biotechnology sector. Sironax is committed to diversity in its workforce and fosters an inclusive work environment.

Qualifications

• 8+ years of statistical programming experience in biotechnology or pharmaceutical industry.
• 2+ years of leadership or project management experience.
• Strong knowledge of CDISC standards and regulatory requirements.

Responsibilities

• Lead management of CROs and ensure quality delivery of outputs.
• Provide statistical programming support for analyses and regulatory submissions.
• Collaborate with cross-functional teams on clinical development initiatives.
• Ensure compliance with FDA/EMA regulatory requirements.

Skills

SAS programming

Leadership

Collaboration

CDISC standards

Regulatory submissions

Education

Bachelor’s or Master’s degree in Statistics, Biostatistics, Computer Science, Mathematics or related field

Tools

SAS

R

Job description

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.