Sr. Manager, Statistical ScienceLocation London, United Kingdom Workstyle Hybrid Apply
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
BioMarin Statistical Science, as a function under Data Science, is responsible for designing, capturing, analyzing, and presenting data that can drive key decisions for Clinical Development, Medical Affairs, and other business areas of BioMarin. With a quality-by-design culture, Data Science builds quality data that is fit-for-purpose to support statistically sound investigation of critical scientific questions. The Statistical Science team develops solid analytics that are visually relevant and impactful in supporting key data-driven decisions across BioMarin.
The Statistician is responsible for supporting the Statistical Science Study and/or Program Lead by taking the lead on assigned study team tasks, such as SAP development and CSR review, in a manner that meets expected quality standards and time frames.
The Statistician role will execute those activities below as assigned and under the guidance of, the Statistical Science Program or Study Lead to support the overall completion of a study:
- May lead statistical activities for an assigned study working with clinical/medical lead and clinical operations.
- Close collaboration with statistical programming and data management.
- Understand regulatory requirements and assure their application
Biostatistics Deliverable Development and Execution
- Participate in the development and execution of the statistical analysis plan (SAP) and the specifications for the statistical outputs ( Tables/Figures/Listings).
- Contribute to the development, review, and/or quality control of protocols, randomization specifications, Clinical Study Reports (CSRs), eCRF, protocol deviations, Data Quality Review (DQR), clinical publications, and other key-study-related documentation.
- Provide a sample size based on the specification provided by clinical scientists
- Develop analysis specifications for programmers and review/verify analyses and programming codes for quality assurance
- Conduct research (e.g., literature search, simulation studies) to support decision-making
- Participate in development of standard reporting programs for clinical studies
- Participate in development of standard CRFs for clinical data collection
- Provide statistical support for assigned study throughout the study lifecycle and ensure accuracy and reliability of statistical results for all activities.
- Work with representatives from study team and other statisticians to analyze and interpret clinical study data.
- May participate in activities supporting regulatory/HTA submissions.
- Participate in production of HA documents PBRER,/DSUR/IB
- Will work with vendors on specific study deliverables.
- Participate in production of DMC reports.
- Understand and abide by Data Science processes for study execution for all Statistical Science-related study deliverables
- Provide review for documents in development (ex. SOPs, work instructions, templates)
- Keep abreast of literature/advancements in science/medicine/technology in own and related fields of the drug development program
The Statistician will be required to work independently under the supervision of the Statistical Science program Lead. This position will contribute to and make an impact on project or study team outputs.
Hybrid home/office requiring at least one day a week in the office with flexibility to come to office more often if needed.
This role will not manage any direct reports.
- PhD degree preferred, or MS in biostatistics.
- 1+ years clinical trial experience in pharmaceutical and/or biotech company. Work terms in industry will also be considered.
- Understanding of clinical drug development in industry required
Computer work utilizing common business software programs and hardware solutions such as MS Word, Project, Excel and PowerPoint.
Statistical software: SAS (required)/ R (optional)
Good programming skills .
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.