Biostatistician

Key Skills

Analytical and Problem solving, Biostatistics, Design, Effective communication skills, Presentation skills, Python Programming, R Programming, SAS, Statistics

Job Description

Act as the lead biostatistician for one or more clinical trials within a single clinical program or across multiple clinical programs.

• Provide input on study design, efficacy and safety endpoints, and planned statistical analyses. Run simulations to support study design, decision rules, and sample size design. Review and approve protocols developed by national and international external partner biostatisticians (participate in protocol development if not delegated to external partner biostatisticians).

・Support in all statistical operational aspects of clinical trials (randomization specifications, statistical analysis plans, interim analyses, safety reviews, final analyses, etc.), including clinical trial set-up, trial conduct, and interpretation of results , or oversee the biostatistical operations of external partners.

・Communicate appropriately with external partner biostatisticians and the global statistics team regarding statistics-related work. In addition, in collaboration with the Japanese project team, application team, and global statistics team, we will perform work related to applications to PMDA based on the set timeline.

[Required experience]

・Those who can play a role as a statistician in domestic and overseas statistical analysis departments and cross-functional teams.

・Application-related work

・Excellent knowledge of programming languages ​​(SAS/R/Python, etc.)

・English writing and verbal communication skills

・Be proactive and have appropriate problem-solving skills.

・Excellent communication and presentation skills.

[Academic background]

Bachelor degree or above

The job responsibilities for a Biostatistician may include:

・Serving as a Biostatistician Study Lead, responsible for driving statistical input in one or more individual clinical studies within a clinical program or across multiple clinical programs.

・Providing guidance on study design and appropriate statistical input on all aspects of analysis, interpretation of findings and reporting of results. Giving technical and strategic oversight of deliverables outsourced to external CRO’s or vendors. Producing and reviewing statistical deliverables for a submission or other regulatory interactions.

・Performing exploratory statistical analysis to gain novel insight that can be used to help inform the development of existing or new compounds. The role will require the Senior Biostatistician to work effectively with other cross-functional teams within and outside SSI

Delivering statistical excellence to non-clinical development in Preclinical and Research areas, ensuring decision-making takes place within the parameters set by logical and quantitative scientific inference. 

・Create value by working collaboratively with teams in NewMeds, across all therapeutic areas, to deliver appropriate support and fit for purpose approaches across the UCB project portfolio.

・Actively driving innovation within the team and, transversally across SSI. Act as ambassador for SSI, representing the department internally and externally. Works within a Global team.

・Seeks information from the internal and external environment to understand the wider business, scientific and/or commercial context.

【MAJOR ACCOUNTABILITIES】

・Acts as the lead biostatistician for one or more clinical studies within a clinical program or across multiple clinical programs.

・Gives input into the study design, efficacy and safety parameters and the planned statistical analyses. Performs simulations to support choice of study design, decision rules and the sample size. Participates in protocol development if this is not delegated to an external partner biostatistician. Reviews and approves the protocol prepared by the external partner biostatistician.

・Supports or overseas external partner biostatistical support for all statistical operational aspects of the clinical trial, covering trial set up, trial delivery and the readout of results. This includes input into randomization specifications, statistical analysis plans, interim analyses, safety reviews and final analyses.

・Communicates and coordinates all statistical activities with external partner biostatisticians. Ensuring the implementation of global, program and SSI standards by all biostatisticians contributing to the project.

・Provides input on interpretation of results by attending and presenting at the Results Interpretation Meeting (RIM). Reviews and inputs into the clinical study report.

・Assists the biostatistician lead for a program of studies with the statistical deliverables for regulatory submissions and the lifecycle of a development compound.

・Senior Biostatistician with sufficient experience may serve as a biostatistician lead for a program of studies, as agreed to by their line manager.

・Effectively contributes within cross-functional or multi-disciplinary groups

・Stays current with ongoing developments in statistical methods applications in the pharmaceutical industry.

・Acts as a resource for junior biostatisticians on the team.

・Communicates complex issues in nontechnical language by using visuals, simulations and other illustrative techniques.

・Provides statistical sciences training to UCB employees from different disciplines on statistical concepts.

・Seeks opportunity to represent UCB by active participation in external professional/technical forum and defend statistical strategy in front of regulatory authorities when required.

・Contributes and reviews abstracts, posters, presentations and manuscripts for publication and ensures accuracy of all biostatistical aspects of such documents

・Adheres to the company SOPs and working procedures

EDUCATION & QUALIFICATION

・Must be able to serve as a statistical expert within the statistical analysis department and in cross-functional teams both nationally and internationally.

∙ Clinical application related work

・Excellent knowledge of programming languages (SAS/R/Python, etc.)

・Excellent written and oral communication skills in English

∙ Ability to take initiative and solve problems appropriately

・Excellent communication and presentation skills