Sr. Manager, Biostatistics

Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.

But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.

Scope of the Role

The Senior Manager, Biostatistics plays a critical role within the Global Biometric Sciences (GBS) organization, providing statistical leadership across clinical development programs from Phase I through Phase IV. Acting as the statistical lead for assigned studies, programs, or assets, you will contribute to the design, analysis, interpretation, and reporting of clinical trial data while ensuring compliance with regulatory requirements and industry standards.

This position requires close collaboration with cross-functional stakeholders, including Clinical Development, Medical Affairs, Data Management, Statistical Programming, Clinical Operations, Pharmacovigilance, Translational Sciences, and external partners. In addition to serving as a technical expert, you will provide strategic guidance on clinical development plans, innovative trial designs, regulatory submissions, and evidence generation activities.

Your Role

As Senior Manager, Biostatistics, you will:

Statistical Leadership & Clinical Development

• Provide expert statistical input into the design and conduct of Phase I-IV clinical studies.
• Contribute to protocol development, sample size calculations, simulations, power analyses, and complex randomization strategies.
• Support compound development plans and provide strategic statistical consultation across development programs and lifecycle management activities.
• Represent Biostatistics in Core Clinical Development Teams, asset teams, and GBS governance meetings.

Study Execution & Analysis

• Develop Statistical Analysis Plans (SAPs) aligned with regulatory expectations and study objectives.
• Coordinate statistical analyses, data validation activities, interim analyses, and interpretation of study results.
• Oversee the preparation of topline results, Clinical Study Report outputs, and post-hoc analyses.
• Organize blinded data reviews, dry runs, and database lock readiness activities, ensuring data quality and compliance with Risk-Based Quality Review (RBQR) principles.
• Review study-related documentation, including protocols, eCRFs, Data Validation Specifications, and Clinical Study Reports.

Regulatory & Scientific Contributions

• Contribute to regulatory submission activities, including Integrated Summaries of Safety (ISS) and Efficacy (ISE).
• Ensure statistical deliverables support global regulatory filings and health authority interactions.
• Partner with Medical Affairs and scientific stakeholders to support manuscripts, abstracts, posters, presentations, and publications.
• Stay current on evolving regulatory requirements, statistical methodologies, and Real-World Evidence (RWE) approaches.

Cross-Functional & Vendor Management

• Collaborate with Clinical Operations and Business Operations in the selection and oversight of CROs and external service providers.
• Partner closely with Medical Writing, Data Management, Statistical Programming, Quality & Compliance, and other key stakeholders.
• Support audit and inspection readiness activities, including the implementation of corrective and preventive actions when required.
• Ensure timely filing of statistical documentation within the Trial Master File and other regulated systems.

Program & People Leadership

• Provide statistical leadership for assigned programs, assets, or therapeutic areas.
• Mentor and guide biostatisticians supporting individual studies, fostering collaboration, accountability, and technical excellence.
• Contribute to resource planning and ensure appropriate statistical support across projects.
• Lead or participate in process improvement initiatives that enhance efficiency, quality, and innovation within Biostatistics.

Who Are You

You are a highly experienced biostatistics professional with a strong scientific background and proven expertise in clinical development. You combine technical excellence with strategic thinking, leadership capabilities, and the ability to influence decision-making in a complex, global environment.

Education

• PhD in Statistics, Biostatistics, or a related quantitative discipline with 8-10 years of relevant experience; or Master's degree in Statistics, Biostatistics, or a related health sciences field with 10-12 years of relevant experience in the pharmaceutical, biotechnology, or life sciences industry.

Experience

• Recognized expertise in clinical trial biostatistics and statistical methodologies.
• Demonstrated experience designing, conducting, analyzing, and reporting clinical studies.
• Strong understanding of regulatory requirements governing drug and biologic development.
• Experience managing external vendors, CROs, and strategic partnerships.
• Proven ability to provide technical leadership, mentorship, and scientific guidance.
• Previous exposure to regulatory submissions and interactions with agencies such as FDA and/or EMA is considered an advantage.

Technical Expertise

• Advanced proficiency in SAS and/or R, with knowledge of additional tools such as Python, EAST, nQuery, Phoenix WinNonlin, or similar statistical software.
• Strong knowledge of CDISC standards, including SDTM and ADaM.
• Thorough understanding of ICH Guidelines, FDA requirements, 21 CFR Part 11, and clinical development processes.

Skills & Competencies

• Excellent analytical, statistical, and problem-solving abilities.
• Strong project management and organizational skills with the ability to manage multiple priorities.
• Effective collaborator with experience working in multidisciplinary and cross-functional teams.
• Outstanding verbal and written communication skills in English.
• Strong interpersonal and stakeholder management capabilities.
• Solid understanding of the pharmaceutical industry, competitive landscape, and emerging drug development trends.
• Continuous learning mindset, adaptability, and the ability to grow with an evolving global organization.
• Leadership style characterized by coaching, empowerment, accountability, and a commitment to excellence.

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.