Dir/Sr. Director, Biostatistics

JOB SUMMARY:
Responsible for designing, analyzing and implementing a wide range of statistical methods (e.g. interim analyses for futility/efficacy, Bayesian methods, etc) and providing rigorous statistical expertise on projects and protocols in support for clinical development. Partners with CRO, data management, statistical programing teams. Develops SAPs, conducts hands on SAS and R programming including simulations; Develop and QCs SDTM/ADaM datasets, tables listings and figures. Develops and adheres to statistical SOPs. Help to maximize the value of clinical trials and real-world data in support of drug development and other scientific strategies. Partners with clinical project and study teams as appropriate. This role will help with critical data interpretations used for internal decision-making and health authority interactions.
ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide statistically rigorous expertise including hands on development on study design, statistical analysis plans, communication of statistical results, project development plans, regulatory issues, and scientific and other product support projects.
• Accountable for timeliness and quality of study/submission level statistical deliverables on assigned projects.
• Write Statistical Analysis Plans including mock TFLs for studies and cross study integrated analyses.
• Partner closely with Data Management on eCRF and DB design, data cleaning and activities to support in stream data cleaning, freezing/locking subjects and database lock.
• Partner closely with Statistical Programming to draft SDTM/ADaM specifications, QC datasets and tables, listings and figures.
• Support regulatory responses and interactions, CSRs, IB, DSURs, external clinical data presentations at conferences, publications, etc.
• Develop effective collaborations internally and externally including, but not limited to, data management, statistical programming, clinical teams, regulatory and industry professionals.
• Ensure study and project level statistical activities are documented and conducted in compliance with relevant regulatory requirements.
• Provide statistical input and leadership to cross-functional activities, in collaboration with study managers for assigned studies or regulatory submissions.
• Develop SOPs, guidelines, training and process flows for Statistics

• Other projects as deemed appropriate.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

• Advanced degree in statistics or biostatistics; PhD preferred.
• A minimum of 8-12 years of experience in Pharma/Biotech designing phase 1-4 clinical trials, analyzing and reporting clinical trial data.

• A minimum of 8-12 years of experience in R and SAS programming including R packages, graphics (e.g. waterfall, spider, box plots, forest plots, etc) in a clinical trials setting.
• A minimum of 6 years of experience in oncology including regulatory submission experience for oncology medicines.

• Strong technical and statistical expertise including interim analyses, Bayesian approaches, mixed models, survival analysis methods, etc.; expertise in statistical software tools, e.g. EAST,
• Relevant clinical trial, real-world data, and business experience providing an understanding of the processes associated with clinical, regulatory, and marketing operations.
• Capability to provide statistical leadership to cross -functional teams at the protocol or project level.
• Demonstrated track record of collaborating on teams; Strong team-player.
• Positive, can-do, collaborative attitude; high emotional intelligence.
• Effective verbal and written communication skills.
• Ability to multi-task/ prioritize and time management of daily activities.

• Intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, MS Project)
• High attention to detail and accuracy.

• Demonstrates high level of accuracy and effective oral and written communication skills.
• Flexibility within a rapidly changing environment
• Excellent ability to work in a goal and team-oriented setting.
• Well-developed organizational skills and the ability to thrive under pressure.