Associate Director Statistical Programming

TFS HealthScience · Poli, Lazio, Italia · · 70€ - 90€


Descrizione dell'offerta

TFS HealthScience is a leading global midsize 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 of Statistical Programming, home-based in the 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.

The Associate Director of Statistical Programming is responsible for assisting the Director in leading biometric operations within the Statistical Programming department.

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. Assist the Director in proposal development, project allocation, budget projections, and client presentations as needed. Serve as a resource for the department, ensuring scientific integrity in the application of statistical methodology to clinical trials.
  3. Manage staff in accordance with organizational policies and applicable regulations.
  4. Oversee the development of direct reports by planning, assigning, and directing work, setting goals, appraising performance, mentoring, and guiding professional development, and working with the Director to address any issues.
  5. Ensure high quality, timeliness, and an expert review process for the department's deliverables.
  6. Provide advanced technical expertise for internal and external clients. Maintain knowledge of developments in Biostatistics, clinical trial methodology, and regulatory requirements impacting analyses.
  7. Accountable for the project-level work of staff, including awareness of timelines, scope, and resourcing strategy. Guide leads toward financial success at the study level.
  8. Provide feedback on strategy and initiatives, implement them, and collect feedback from the implementation (e.g., metrics).
  9. Develop and/or provide training to staff across the business unit. Ensure compliance with strategies and initiatives.

Qualifications :

  1. A Bachelor of Science (BSc) or Masters degree in statistics or a related discipline; PhD in Statistics or related discipline preferred or equivalent.
  2. Minimum of 10 years of relevant statistical experience in the pharmaceutical or CRO industry with increasing levels of responsibility.
  3. Familiarity with complex statistical methods applicable to Phase I-IV clinical trials.
  4. In-depth knowledge of clinical research regulatory requirements, e.g., Good Clinical Practice (GCP) and ICH guidelines.
  5. Strong working knowledge of SAS, CDISC, and Regulatory Submissions.
  6. Experience in project management, problem-solving, and team leadership.
  7. Ability to effectively communicate with sponsors and internal customers at all levels.
  8. Willingness and ability to travel occasionally.
  9. Excellent verbal and written communication skills in English.

What We Offer

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

A Bit More About Us

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

Our core values—Trust, Quality, Passion, Flexibility, and Sustainability—guide our decision-making at all levels, helping us attract and retain talented individuals who share these values, resulting in high employee engagement and satisfaction. By aligning on these principles, we foster a culture of innovation and excellence, working together to make a difference.

Key Skills

Program assessment, FDA Regulations, Manufacturing & Controls, Program Evaluation, Budget Forecasting, Research Experience, Operations Management, Research & Development, Strategic Planning, Contract Management, Leadership, Negotiation

Employment Type : Full Time

Experience : 10+ years

Vacancy : 1

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Candidatura e Ritorno (in fondo)