Principal Biostatistician, R Proficiency

This is a fully remote position, open to applicants in United States.

📋 Description

• Our Principal Biostatisticians deliver statistical and development support while influencing the client’s trials by offering expertise in processes, clinical development plans, concept sheets, and protocols, and may also oversee work conducted by other vendors.

• You will create a comprehensive analytical approach to extract insights from data sources, utilizing statistical methods, machine learning, and deep learning algorithms to unveil actionable insights and streamline processes to save time and effort for repetitive tasks.

• Engage in the creation of study protocols, which includes discussions on study design and sample size calculations.

• Participate in exploratory data analyses to assess emerging study trends, support scientific decision-making, and generate insights throughout the development process.

• Lead and contribute to efficacy analyses and the interpretation of both primary and secondary endpoints.

• Review Case Report Forms (CRFs) and data review guidelines; develop Statistical Analysis Plans (SAPs) that include analysis datasets and TLF specifications.

• Perform statistical analyses and interpret the statistical results.

• Take the lead on study activities as required and provide strategic statistical guidance to cross-functional teams.

• Leverage strong communication skills to clearly present statistical methodologies, assumptions, and the implications of decisions in an accessible manner for non-technical audiences.

• Act as a collaborative team player, demonstrating a willingness to go above and beyond to achieve project goals and meet timelines.

⛳️ Requirements

• A Master's degree in Statistics, Biostatistics, or a related field; a PhD is highly preferred.

• 8-10 years of biostatistics experience in supporting clinical trials within the pharmaceutical or biotechnology sectors, with a preference for candidates with CRO experience.

• 3-5 years of experience as a Study Lead collaborating with cross-functional development teams.

• Extensive background in study design, sample size determination, protocol development, SAP creation, efficacy analyses, and the preparation of clinical study reports, including integrated summaries for regulatory submissions (ISS/ISE).

• In-depth knowledge and practical expertise in advanced statistical methodologies, including mixed models, longitudinal analyses, and simulation techniques.

• Proven experience in conducting exploratory statistical analyses to facilitate clinical development and decision-making.

• High proficiency in R for statistical analyses, simulations, data visualization, and advanced modeling.

• Strong SAS programming capabilities, including quality control of critical outputs, efficacy and safety tables, and close collaboration with Statistical Programmers.

• Comprehensive understanding of ICH guidelines and regulatory requirements.

• Solid grasp of CDISC standards for regulatory submissions.

• Experience in generating ADaM specifications and performing programmatic reviews of analysis datasets.

• Regulatory submission experience (ISS/ISE) is highly desirable.

• Excellent communication skills with the ability to articulate statistical methodologies and their implications to both technical and non-technical stakeholders.

• Strong collaborative mindset with a dedication to producing high-quality work under tight deadlines.

• Capability to excel in a dynamic environment, manage uncertainty, and adapt to shifting priorities.

🏝️ Benefits

• Our dedication to the development of our staff is only matched by our commitment to enhancing treatment options available to patients.

• Cytel offers consistent training, development, and support.