- The Lead Biostatistician will work with Medical Affairs biostatisticians and MedHub biostatistics and programming personnel to implement statistical analysis plans and provide QC- d data packages including tables, figures, and listings for use in publications (i.e. abstracts, posters, oral, presentations, and manuscripts)
- The Lead Biostatistician will mentor MedHub biostatistics and programming personnel through projects, and ensure they and their team members are current with advanced statistical techniques
- The Lead Biostatistician will ensure SOPs are followed and timelines and quality metrics are met
- Local biostatistics and programming teams
- Global Medical Affairs biostatisticians
- Global Medical Affairs Scientific Communications personnel
People:
- Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product - with an objective to develop statistical data outputs
Feedback from stakeholders (end customers) on overall satisfaction
Performance/Process:
- Conduct appropriate post-hoc statistical analyses of clinical trial data
- Design, develop, test, implement, and document statistical programming in high-level software packages e.g. SAS
- Produce well documented data packages that include tables, listings, and figures
- Work closely with Senior Biostatisticians and Senior Programmers to develop and implement project QC plans and timelines
- Review appropriate biomedical and clinical research literature related to assigned project(s)
- Adherence to timeline
- Adherence to quality target
- Feedback from stakeholders (end customers) on satisfaction with services provided
Customer:
- Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables
- Feedback from stakeholders (end customers) on satisfaction with services provided
Knowledge & Skills Required for the job :
- Stakeholder management
- Project management
- Staff management
- Ability to work independently and within a team environment
- Advanced knowledge of SAS statistical procedures
- Excellent English language knowledge - written and spoken
Qualification:
- Master's degree/Ph.D. in Biostatistics or Statistics or Epidemiology and 6-8 years (Ph.D.)/8-10 years (M.Sc.) of experience required
Requirement of the job:
- Pharmaceutical/healthcare industry exposure
- High proficiency in statistical methods used in the pharmaceutical industry
- Advanced SAS and other statistical computing software skills in a clinical data environment across multiple therapeutic areas
- Expertise in the use of data management applications and database/file structures, specifically with respect to CDISC requirements
- Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines
- Capacity to respond to unscheduled changes in project workload
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