At a Glance
- Tasks: Lead statistical contributions to clinical development and ensure robust data analysis.
- Company: Join a leading pharmaceutical company focused on innovative hematology solutions.
- Benefits: Competitive salary, hybrid work model, and opportunities for professional growth.
- Other info: Collaborate with cross-functional teams and engage with regulatory authorities.
- Why this job: Make a real impact in clinical trials and regulatory submissions in a dynamic environment.
- Qualifications: PhD or MS/MA in statistics with 10+ years in clinical development.
The predicted salary is between 80000 - 100000 £ per year.
The Director, Biostatistics, leads the full scope of statistical contribution to a clinical development program, including life cycle management. The AD provides for statistical excellence in clinical development plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development and other key stakeholders.
Responsibilities and Accountabilities
- Define the statistical strategy and ensure appropriate statistical methodologies applied to the clinical development plan, study design and data analysis for clinical trials, and regulatory submissions.
- Provide statistical insight into execution of clinical development, to ensure study conduct leads to a statistically sound and robust data package, maximising probability of program success.
- Interpret analysis results and ensure reporting accuracy in study reports and regulatory documents, abstracts, posters, oral presentations, manuscripts and written reports to effectively communicate results of clinical programs and studies.
- May serve as the point of contact for one or more PSTs within the TA.
- Lead or provide oversight to the analysis delivery and quantitative evaluation of clinical trials, and integrated analysis.
- Represent Biostatistics in interactions with regulatory authorities (e.g., FDA, EMA, PMDA), which includes leading written responses to regulatory questions and attending regulatory meetings.
Qualifications
- Education: PhD or MS/MA in statistics or related field.
- Experience: 10+ years of experience in clinical development within the pharmaceutical or biotechnology industry.
- Demonstrated leadership in statistical contributions to clinical programs and regulatory submissions.
- Experience partnering with cross-functional teams and interacting with health authorities.
- Experience managing external partners (CROs, consultants).
- Strong statistical methodology knowledge and clinical trial design expertise.
- Ability to collaborate and influence across functions and levels.
- Excellent communication and interpersonal skills.
- Experience with CDISC standards, programming oversight, and statistical operations.
- Strategic and analytical mindset with a focus on execution.
- Ability to work in a matrixed environment and lead through influence.
Working Conditions
This is a hybrid position. Three in-office days per week are required.
Travel Requirements
Occasional travel to scientific conventions.
Director Biostatistics - Hematology employer: CSL
As a leading employer in the pharmaceutical industry, we offer an exceptional work environment that fosters collaboration and innovation. Our commitment to employee growth is evident through continuous professional development opportunities and a supportive culture that values diverse perspectives. Located in a vibrant area, our hybrid work model allows for flexibility while ensuring meaningful contributions to groundbreaking clinical programs.
