- The Senior Biostatistician is responsible to lead and manage all biostatistics related activities on assigned programs/projects including the design, planning and preparation of all Biostatistics and Statistical Reporting deliverables in support of clinical development (e.g. program level standards), trials (Statistical Analysis Plans (SAPs)), and filings (e.g. planning and managing submission activities including the development of the ISS and ISE).
- In addition, the Senior Biostatistician is responsible to ensure timely, high quality deliverables facilitating where required, appropriate internal review of project deliverables, ensuring that output meets established objectives and is consistent with company standards as well as Health Authority requirements (SOPs, GCP and Regulatory guidelines).
- Collaborate in the process of protocol development, selecting an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol.
- Author or review Statistical Analysis Plans (SAPs), including development/review of mock-up displays for tables, listings, and
- Generate and/or review randomization schedule(s). Perform ongoing monitoring of actual randomization schemes applied by IVRS/IWRS.
- Participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter
It is expected that Senior Bio statistician will have to travel internationally, as required by the Project or Department activities.
- The Senior Bio statistician will report to and will be supervised by the VP Clinical Development, within the Clinical Development Department.
Qualification and Experience:
Master’s Degree in Biostatistics or related discipline. PhD in Biostatistics or related discipline, strongly preferred.
Excellent written and verbal communication skills in English, including grammatical/ technical writing skills. Any additional language is a “nice to have“.
- Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel, Powerpoint and in addition statistical software packages (SAS, S+, R).
- Good knowledge and understanding of the International Conference of Harmonization-Good Clinical Practices (ICH-GCP) and experience with the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and CDISC Analysis Data Model (ADaM) is a requirement for this role.
- Excellent knowledge of statistical theory including experimental design, categorical data analysis, analysis or variance (covariance), survival analysis, and non-parametric methods.
- 3-5 years’ experience in clinical trials or equivalent combination of education and experience.
- A proven track record of effective project management is required as well as a high level of interpersonal and communication skills (written and verbal) to effectively convey statistical concepts
- In addition, a solid experience with all phases of clinical drug development and a comprehensive understanding of applied statistical principles and modeling in the design and analysis of clinical trials is required.
- You should be able to work independently as well as feel comfortable in being part of a multifunctional team.
- Therefore, both self-organizational, leadership and interpersonal skills are required for this role.
- Furthermore, you lead, participate and make positive contribution to team meetings by being an active and open communicator, and by sharing knowledge and experience with other team members. Your daily behavior and actions should be driven by the company’s values, combined with a tolerant, considerate and team-work attitude.