Associate Director, Statistical Programming

TFS HealthScience; Napoli; Remoto; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A global Contract Research Organization in Italy seeks an Associate Director for Statistical Programming. This role involves strategic planning and management within biometric operations, ensuring high-quality deliverables while leading a team. Candidates should have 10+ years in statistical roles within pharma or CRO, alongside advanced knowledge of SAS, CDISC, and regulatory guidelines. The position offers competitive compensation and opportunities for growth in a dynamic environment.

Servizi

Competitive compensation package

Comprehensive benefits

Opportunities for personal and professional growth

Competenze

• Minimum of 10 years relevant statistical experience in the pharmaceutical or CRO industry.
• In-depth knowledge of clinical research regulatory requirements.
• Ability to deal effectively with sponsors and internal customers.

Mansioni

• Assist the Director in strategic planning and resource allocation.
• Manage staff in accordance with organization’s policies.
• Oversee the development and performance management of direct reports.

Conoscenze

Statistical software (SAS)

Knowledge of CDISC guidelines

Project management

Team leadership

Advanced communication skills

Formazione

Bachelor of Science (BSc) or Master’s degree in statistics

PhD in Statistics or related discipline

Descrizione del lavoro

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing, and Functional Service Provider (FSP) solutions.

Join Our Team as an Associate Director, Statistical Programming - home based in UK, Italy or Sweden.

About this role

As part of our Global Biometrics team, you will work alongside passionate and innovative professionals to ensure our customers achieve their goals.

Associate Director, Statistical Programming is responsible for assisting the Director in leading biometric operations within related departments - Statistical Programming.

Key Responsibilities

1. Assist the Director in strategic planning, leading initiatives, and resource allocation for the department. Participate by offering oversight across studies and/or customers including guidance on documentation and output development/review.
2. Manage staff in accordance with organization’s policies and applicable regulations.
3. Oversee development of direct reports by planning, assigning, and directing work, setting goals, appraising performance, mentoring, and guiding professional development, working with the Director to address any issues.
4. Ensure high quality, timeliness, and expert review process of the deliverables from the department.
5. Provide advanced technical expertise for internal and external clients. Maintain knowledge and awareness of developments in Biostatistics and clinical trial methodology, and regulatory requirements that impact analyses.
6. Accountable for the project-level work of staff including awareness of timelines, scope, and resourcing strategy. Responsible for guiding leads toward financial success at a study level.
7. Provide feedback to draft strategy and initiatives. Implement strategy and initiatives and collect feedback from the implementation (e.g., metrics).
8. Develop and/or provide training to staff across the business unit. Ensure compliance with strategy and initiatives.

Qualifications

1. A Bachelor of Science (BSc) or Master’s degree in statistics or related discipline; PhD in Statistics or related discipline preferred or equivalent.
2. Minimum of 10 years relevant statistical experience in pharmaceutical or CRO industry with increasing levels of responsibility.
3. In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
4. Strong working knowledge of SAS, CDISC, and Regulatory Submissions.
5. Experience in project management, problem-solving, and team leadership.
6. Ability to deal effectively with sponsors and internal customers at all levels.
7. Willingness and ability to travel on occasion.
8. Excellent verbal and written communication skills in English.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

• Together we make a difference.