Associate Director, Biostatistics - IQVIA Biotech (m / w / d)

IQVIA Biotech has an exciting position within its EU Biostats team. As the Biotech and Emerging Biopharma arm of IQVIA, we continue to grow and win new business. Historically IQVIA Biotech focused on Oncology, Dermatology and Medical Device studies but with the addition of CNS, Immunology and Cardiovascular we have a need for a strong Lead Statistician.,

• Collaborate with internal program staff and sponsors on the implementation and analysis of statistical aspects of research protocols.
• Provide statistical consultation for clinical programs, including but not limited to protocol development, randomization, sample size assessments, efficacy evaluations, and data review.
• Define and manage project timelines for specific projects, and ensure that project timelines are met for both internal and external clients.
• Ensure that project tasks are completed with superior quality for both internal and external clients.
• Review, approve and develop, as needed, the statistical analysis summary and analysis plans, including textual description of planned analysis and mock-ups of data displays.
• Oversee and/or perform statistical analyses, including hypothesis testing and modeling.
• Interact with Medical Writers to ensure appropriateness of data inferences and/or write pertinent sections of a clinical study report.
• Interface with clients and/or regulatory agencies as the project biostatistician.
• Ability to oversee a program of studies.
• Assist the Manager and Sr. Director in defining and maintaining departmental standards, SOPs and working practices.
• Provide leadership, mentoring and statistical support for Biostatistics staff.
• Assist the Manager and Sr. Director in development of training materials and execution of training in Biostatistics and general Clinical Reporting activities, for new and existing Clinical Reporting staff.
• Make presentations to clients and other interested individuals about the processes and procedures of the Clinical Reporting department.
• Assist the Manager in the coordination of project tasks and resources across the Biostatistics group, and act as backup during the Manager's absence, as assigned.
• Perform other duties as assigned.
  
  We're looking for enthusiastic and independent professionals with great communication skills who are willing to work from home with an international team. This is the perfect opportunity to join an established department and develop leadership skills.
IQVIA Biotech specialises in working with smaller biotech and emerging biopharma clients and as such we have a vibrant, fast-paced work environment. You'll be working with a lot of the new innovative and upcoming research groups across a variety of therapy areas. The ideal candidate will possess extensive oncology drug development experience across a broad range of oncology indications, with demonstrated expertise in applying advanced statistical methodologies throughout the clinical development lifecycle. They should have the technical expertise to provide senior-level statistical review and oversight of Statistical Analysis Plans (SAPs), ADaM specifications and datasets, Tables, Listings, and Figures (TLFs), and other key study deliverables, ensuring scientific rigor, quality, and consistency across programs. The candidate will be an effective people leader with a proven ability to mentor, develop, and support biostatistical staff across global regions, including Europe and JPAC. Strong customer engagement and relationship management skills are essential, including the ability to serve as a trusted statistical advisor to emerging biopharma customers who may have limited experience with clinical development, regulatory requirements, and statistical considerations. The successful candidate will also have experience supporting regulatory submissions and interacting with regulatory agencies. Experience participating in and leading bid defense meetings is expected, along with the ability to coach and develop future Statistical Team Leads by strengthening their customer-facing, business development, and presentation skills.,
• Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research.
• Advanced knowledge of statistical methods used in the design and analysis of Phase I-IV clinical trials.
• Experience with SAS Base and SAS Stat.
• Experience with other statistical software packages, such as N-Query, S-Plus.
• Ability to work creatively and independently to carry out assignments of a complex nature.
• Must be skilled in effective time management.
• Ability to work effectively and cooperatively with other professional staff members.
• Ability to communicate effectively, both verbally and in writing, with all levels of staff and with the public., Masters-level degree in Statistics, Biostatistics or related field with eight years relevant CRO industry or biotech experience; or
• Doctorate-level degree in Statistics, Biostatistics or related field with six years relevant CRO industry or biotech experience.
• Data handling and analysis experience.
• Excellent interpersonal and organization skills.
  
  IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.