Senior/ Principal Biostatistician

PureCDM is dedicated to providing a full range of expert biostatistical support to clients in the pharmaceutical, biotechnology, and MedTech industries. Our mission is to break down the complexities of data, translate technical analyses into clear, actionable insights that empower our clients to make informed, impactful decisions. By combining scientific rigor with practical application, we enable our clients to confidently navigate their clinical and regulatory challenges and bring transformative solutions to market.

Job Overview:

We are seeking skilled Senior or Principal Biostatisticians to join our team. In this role, you will serve as the lead biostatistician for multiple clinical trials across several therapeutic areas and be responsible for the development of statistical analysis plans and the accuracy and consistency of statistical tables, figures, and data listings. You will work closely with cross-functional teams to ensure statistical integrity, regulatory compliance, and high-quality of statistical deliverables.

Main Activities

• Lead biostatistician: Serve as the primary contact with the client and project team for all biostatistical services, such as development of statistical analysis plans, producing randomization schedules, reviewing statistical outputs produced by the programming team to assure high quality and accuracy, and provide statistical guidance for clinical study reports and regulatory packages

• Protocol & SAP Development: Collaborate with clients to develop trial protocols and statistical analysis plans to incorporate efficient study designs, perform sample size calculations, and apply the appropriate statistical methodologies meeting the client's drug development goals and regulatory standards

• Data Analysis & Interpretation: Oversee statistical analyses and collaborate with the sponsor and clinical and medical writing teams to interpret and report clinical trial results in a rigorous and meaningful manner

• Regulatory Compliance & Documentation: Provide statistical guidance for regulatory submissions using statistical methodologies that meet FDA, EMA, and ICH guidelines, and support or represent the sponsor in interactions with regulatory authorities

• Cross-functional collaboration: Work with data managers, clinical researchers, and project managers to ensure effective trial execution, from planning to reporting

Education:

Ph.D. or Master's degree in Statistics, Biostatistics, or a related quantitative field

Experience:

• Minimum of 6 years of experience as a lead statistician for clinical trials

• Minimum of 4 years as a Senior/Principal Biostatistician or equivalent in a CRO setting

• Proficiency with statistical software such as SAS, R, sample size software, and other relevant tools

• Expertise in statistical methodologies relevant to clinical trials, including survival analysis, mixed-effects models, Bayesian methods, adaptive trial designs, multiple imputation, and longitudinal data analysis

• Proficiency with the Estimand framework

• Deep understanding of regulatory requirements (e.g., FDA, EMA, ICH guidelines

• Strong problem-solving and critical thinking abilities with a proactive, solutions-oriented approach

• Excellent written and verbal communication skills, with the ability to translate complex statistical information into clear, actionable insights for clients

Soft Skills:

• Exceptional organizational and project management skills

• Ability to manage multiple projects

• Self-motivated, proactive, and able to work independently and as part of a team

• A deep passion for data-driven decision-making and a commitment to delivering value to clients