Senior Biostatistician

We are working with a pharmaceutical organization with an extensive clinical development program focusing on oncology, inflammatory, and neurodegenerative diseases.

They are currently seeking a talented and experienced Senior Biostatistician to join the Biometrics teams. The successful candidate will play a pivotal role in various aspects of statistical analysis, protocol development, and study design.

Responsibilities include:

• Craft the Statistical Sections of Protocols.
• Evaluate and contribute to the Study design.
• Determine the appropriate sample size.
• Examine the Case Report Form (CRF).
• Assess the Edit Check Document, especially for critical modules like RECIST 1.1.
• Compose randomization specifications and coordinate activities with the IWRS vendor.
• Develop Statistical Analysis Plans (interim and final versions as needed).
• Conduct Statistical Analysis (Efficacy and Safety) using SAS.
• Ensure the quality of all generated outputs.
• Fulfill the role of validator as necessary.
• Offer Statistical Consultancy for ongoing projects.
• Conduct Futility and Efficacy analyses for interim assessments.
• Defend the Statistical Analysis during IDMC meetings as required.
• Create specifications for efficacy analysis and review those for safety analysis.
• Evaluate the Clinical Study Report and provide statistical inputs.
• Perform exploratory analysis as deemed appropriate.

Requirements:

• Ph.D. in Statistics with a minimum of 3 years of relevant pharmaceutical (or CRO) industry work experience, or Masters in Statistics or equivalent with a minimum of 5 relevant pharmaceutical (or CRO) industry work experience.
• Good Knowledge of SAS. Preliminary working knowledge of R.
• Good Understanding of CDISC Concepts.
• Good understanding of ICH guidelines.

To find out more, please contact Patricia Sousa (patricia.Sousa@lifescirecruitment.com)

At Life Sciences Recruitment Ltd (LSR), we are a Global Life Science recruitment firm that specialises in partnering with start-ups, fast-growing biotech and pharmaceutical organisations.

Founded in 2021, we recognised the need for a company with the insights, knowledge and credibility of a search firm but offering a contingent service.

As one of the most competitive and fast-paced industries globally, succeeding and growing in the life sciences business requires a combination of creativity, technical expertise, and business savvy. At LSR, to find the best talent for your organisation, our dynamic recruitment consultants tap into our unparalleled network of contacts and apply a quality-based approach to a contingent search model tailored to your needs. We provide the most sought after candidates to fit your requirements ranging from temporary placement to Fortune 500 companies!

LSR is a privately owned and independent recruitment company focused on the Life Sciences industry. We are a subsidiary of Morgan Prestwich (MP), Europe's leading boutique Life Sciences executive search and advisory firm.

Contact us today to learn more about our recruitment services.