Principal Biostatistician, Sr Biostatistician – R/Rshiny

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

📋 Description

• Establishes and sustains an exceptional R-based computing environment.

• Incorporates missing functionalities into applications and addresses bugs in current applications.

• Evaluates the market for available data visualization tools and integrates both internal and external applications into our operational framework.

• Organizes and conducts user training sessions while providing on-demand user support.

• Remains informed about the latest technical advancements available globally.

• Acts as a resource for the statistical department, mentors biostatisticians in job skills, and develops or supervises training plans and materials for Biostatistics associates.

• Facilitates training sessions for new hires and enhances the skills of current personnel.

• Oversees the activities of other biostatistics staff on assigned projects to guarantee timely delivery of high-quality work.

• Conducts independent reviews of project outputs produced by fellow biostatisticians within the department.

• Supports all statistical tasks throughout the project lifecycle, from protocol to Clinical Study Report (CSR).

• Prepares or supervises the creation of Statistical Analysis Plans (SAPs), including the development of well-designed mock-up displays for tables, listings, and figures.

• Collaborates with sponsors as necessary.

• May take on the role of Lead Biostatistician for the statistical components of the protocol, generation of randomization schedules, and contributions to the clinical study report.

• Creates or evaluates programming specifications for analysis datasets, tables, listings, and figures.

• Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to confirm that protocol criteria are met and all required data is captured to support a high-quality database and planned analysis.

• Implements company objectives and devises alternative solutions to tackle business and operational challenges.

• As the biostatistics representative on project teams, engages with representatives from other departments, prepares for internal meetings, contributes ideas, and shows respect for the opinions of others.

• Conducts and participates in the verification and quality control of project deliverables, ensuring that outputs align with expected results and are consistent with the analysis outlined in the SAP and specifications.

• May lead complex or multiple projects (e.g., submissions, integrated analyses) and attend regulatory agency meetings or respond to inquiries as needed to support the statistical analysis results of clinical trials on behalf of the sponsor.

• Manages scheduling and time constraints across various projects, sets objectives based on management priorities, discusses time estimates for study-related activities with biostatistics management, adjusts to changes in timelines or priorities by reorganizing daily workloads, and proactively communicates any challenges in meeting these timelines to biostatistics management.

• Tracks progress on study activities against agreed milestones and ensures that study timelines for project deliverables are met.

• Identifies out-of-scope tasks and escalates them to management.

• Provides statistical programming support as required.

• May participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician.

• May serve as a voting statistician on DSMBs and/or DMCs.

• Provides input and reviews while adhering to applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).

⛳️ Requirements

• Rshiny experience is essential for this position.

• A PhD or MS in biostatistics, statistics, mathematics, or data science with a strong focus on computing/informatics is required.

• A minimum of two years of experience as a statistician, with considerable time spent in the Pharma, Biotech, or similar sectors.

• Proficient in R and R-shiny, with extensive experience in clinical data structures and data programming.

• Expertise in functional and object-oriented programming, with knowledge of JavaScript/TypeScript, HTML, and WebGL.

• Experience with CUDA/GPU programming, cloud computing, GitHub, and web hosting.

• Strong communication skills, with the ability to work independently and collaboratively, presenting complex issues clearly.

• A team player.

• Proficiency in English is required.

🏝️ Benefits

• We are dedicated to fostering the development of our employees through career progression and professional growth.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• We are committed to cultivating an inclusive culture where you can truly be yourself.