Senior Biostatistician

1 month ago

Cambridge, Cambridgeshire, United Kingdom Pfizer Full time
ROLE SUMMARY

This position will provide statistical support for projects in the Inflammation and Immunology disease area in Global Product Development. The qualified candidate will collaborate and work closely with project or study teams and provide statistical expertise in designing clinical trials, developing protocols, writing statistical analysis plans, performing statistical analyses, interpreting and presenting results, writing/reviewing reports, and publishing manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries. Successful candidate will make contributions through quantitative and creative thinking as well as proactively staying in the front of the current development of statistical methodologies.

ROLE RESPONSIBILITIES
  • Provide statistical input into project development plans, study design, statistical analysis plans.
  • Be accountable for quality statistical deliverables according to study timelines.
  • Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards.
  • Provide data presentation plan and interpretation of statistical analysis results and contribute to the clinical trial reports.
  • Provide support for publications and scientific presentations of study results.
  • Provide input to the Statistics Group Lead to plan support for assigned studies and submissions.
  • Communicate and collaborate with other project statisticians to ensure consistency of statistical approaches across studies.
  • Participate in research on statistical methodology and its applications pertinent to the business needs of the organization.

SKILLS, QUALIFICATIONS & EXPERIENCE
  • MS in Statistics/Biostatistics or related field with 4+ years' experience or PhD in Statistics/Biostatistics or related field
  • Effective verbal and written communication skills
  • Understanding of broad statistical theory and its application
  • Experience with SAS or R programming languages
  • Effectively and clearly explaining statistical concepts to colleagues without statistical training
  • Work collaboratively as a team member

Preferred qualifications
  • Strong computational skills
  • Experience with different study designs, protocol development, and statistical analysis plan writing
  • Experience with statistical modelling of clinical data and statistical inference

ORGANIZATIONAL RELATIONSHIPS
  • As a key member of project team, this position will interact directly with Clinical (Clinicians), Clinical Pharmacology, Statistical Programming, Data Management, Regulatory Strategy and Operations, Medical, Outcomes Research, Commercial, Operations and contract organizations supporting project deliverables.

Closing Statement

The successful candidate will be a key member of the project team, working closely with clinicians, pharmacologists, and other stakeholders to provide statistical support for projects in the Inflammation and Immunology disease area. The candidate will be responsible for designing clinical trials, developing protocols, and writing statistical analysis plans, as well as providing input to the Statistics Group Lead to plan support for assigned studies and submissions. The candidate will also be responsible for communicating and collaborating with other project statisticians to ensure consistency of statistical approaches across studies. The ideal candidate will have a strong background in statistics and biostatistics, with experience in SAS or R programming languages and the ability to effectively communicate complex statistical concepts to colleagues without statistical training. The candidate will also have strong computational skills and experience with different study designs, protocol development, and statistical analysis plan writing. The successful candidate will be a key contributor to the project team, working collaboratively to deliver high-quality results and publications.

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