At a Glance
- Tasks: Lead statistical strategies for clinical trials and collaborate with diverse teams.
- Company: Proclinical, a leader in biostatistics and clinical development.
- Benefits: Competitive salary, flexible work locations, and opportunities for professional growth.
- Other info: Dynamic role with opportunities to innovate and improve clinical data analysis.
- Why this job: Make a real impact in healthcare by influencing clinical development and regulatory submissions.
- Qualifications: Advanced degree in Biostatistics or related field and expertise in statistical methodologies.
The predicted salary is between 70000 - 90000 £ per year.
Proclinical is seeking a Senior Manager, Biostatistics to oversee the statistical strategy and execution for clinical programs within a therapeutic area.
This role involves collaborating with cross‑functional teams, contributing to clinical development plans, and ensuring high‑quality statistical methodologies are applied to study designs and data analyses.
The position can be based in Zurich (Switzerland), King of Prussia (USA), Waltham (USA) or Maidenhead (UK) and requires on‑site presence three days per week at one of the specified locations.
Responsibilities Define and implement statistical strategies for clinical trials and regulatory submissions.
Collaborate with cross‑functional teams to influence clinical development plans and governance reviews.
Provide statistical expertise for innovative study designs, including Go/No‑Go criteria and probability of technical success calculations.
Plan and oversee project‑wide analyses, ensuring timely delivery of interim and final results, including integrated analyses for submissions.
Represent Biostatistics in regulatory interactions with agencies such as FDA, EMA, and PMDA.
Interpret analysis results and ensure accuracy in study reports and regulatory documents.
Manage outsourcing operations or collaborate with internal statistical programmers to ensure quality deliverables.
Support or lead departmental and organizational improvement initiatives.
Prepare abstracts, posters, presentations, and reports to communicate clinical program results effectively.
Key Skills and Requirements Advanced degree (Ph D or MS) in Biostatistics, Statistics, or a related field.
Expertise in statistical methodologies and leadership in clinical development strategies.
Experience in regulatory submissions and interactions with major regulatory authorities.
Familiarity with SAS and/or R, CDISC standards, and advanced statistical methodologies.
Strong interpersonal and communication skills, with the ability to work collaboratively in a matrix environment.
Knowledge of clinical development processes and regulatory guidance.
Proven ability to innovate and apply creative methodologies in clinical data analysis. #J-18808-Ljbffr
