- Doctoral Degree
- Master's Degree
- Statistical Software
- Clinical Trials
The Senior Biostatistician will perform scientific statistical functions in support of the company’s Global Medicines Development and Affairs (GMDA) area with some guidance and mentoring on new and complex issues. He/She will complete assigned work in a resourceful, self-sufficient manner and create alternative approaches to achieve desired results if needed. He/she should possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset.
The Senior Biostatistician works under the supervision of the Biostatistics project or program lead.
Is responsible for all scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations.
Possesses an advanced understanding of modern drug discovery and development processes. Represents Biostatistics as a member of clinical trial teams, providing strategic input and expert technical guidance to team members.
Directs own technical leadership and project teams to more meaningful and/or productive ends.
Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) in order to facilitate the review, summary, and dissemination of key study data/results.
Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with good quality.
Contributes to external interactions with regulators, payers, review boards, etc.
Develops statistical section of protocols, including sample size estimates and randomization plan.
Contributes to clinical study reports (CSRs) and related processes. Also authors or co-authors methodological or study-related publications and posters. Provides input into programming specifications and review.
Leads implementation of innovative designs and analysis methods at the study level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others.
Contributes to departmental working group efforts on various technical and operational issues.
Ph.D. in Biostatistics and 0-3 years of relevant work experience, or
M.S. in Biostatistics and 3+ years of relevant work experience
Competence with SAS and R statistical software
Demonstrated understanding of statistical methods used in drug development
Ability to show critical thinking with logical problem-solving
Excellent written and verbal communication skills
Excels in a team environment
Collaborates well with non-statisticians