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

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

Job Location: Reading, Berkshire, United Kingdom

Job Location Type: Remote

Job Contract Type: Full-time
Job Seniority Level:

Job Description

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.

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.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

- 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