Manager, Biostatistician

As a Manager, Biostatistics, a typical day might include:

• With occasional supervision and guidance from senior departmental staff, provide support to a clinical study team and strategic project team on all relevant statistical matters. Working directly with the medical directors and other study personnel, act as liaison to study team, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis. Defend design at management forums (DPR and PRC).
• With limited supervision and guidance from senior departmental staff, contribute to design of a clinical study and help draft protocols or amendments. Perform relevant sample size calculations.
• Develop statistical analysis plan (SAP). Perform analyses and author statistical methods and results sections of the clinical study report (CSR). Provide statistical insight into interpretation and discussion of study results. Contributes tables and figures for management presentations.
• Under limited supervision and guidance of experienced statisticians, contributes to clinical trial teams. Attends GCST and SPT on straightforward programs to represent department.
• Independently prepares TFLs to support CSRs, DSURs, IB and other documents. Collaborates with Medical Writing and Clinical to ensure tables are complete. Supports TFL production for ISE/ISS for submissions. Contributes to regulatory submissions.
• Under limited guidance of senior staff, supports preparation of material to be used in regulatory interactions, including drafting analysis plan under supervision/guidance and production of TFLs to be used in regulatory meetings, slides for ACMs, etc.
• Contributes to authoring of regulatory background packages, including those for pre-IND, EOP2, and pre-BLA meetings. Will contribute background material for ACMs and perform additional analyses as required for labeling negotiations. Attends pre-IND, EOP2, and pre-BLA meetings with experienced statistician.
• Contributes to technical working groups by developing new methodology and conducting simulation studies under the supervision of senior departmental staff. Contributes to revising SOPs as appropriate

This role might be for you if you have:

• Knowledge of advanced clinical trial design concepts, such as non-inferiority, adaptive methods, type-I error protection, dynamic randomization, and sample size estimation in complex settings
• Knowledge of advanced statistical methodologies applicable to clinical trials, such as survival analysis, stratified or covariate analyses, sequential methods, and strategies for handling missing data
• Able to work in departmental computing environment, do advanced statistical analyses.
• Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines)
• Ability to clearly describe advanced statistical techniques and interpret results
• Ability to formulate statistical objectives, design, and analyses for complex clinical projects
• Ability to meet timelines for deliverables such as topline results and final analyses.
• Good communication & developing negotiation skills, and able to manage internal team and CROs
• SAS, S-Plus/R, Sample size calculation software (e.g., East and Nquery)

To be considered for this opportunity, you must have the following:

• PhD + 2 or MS+8 years biotech/pharma experience
• Experienced PhD. Show greater independence and ability to initiate activities on own.
• Able to serve independently as study statistician for moderately complex studies or statistician for a less complex indication and to contribute to or lead non-project objectives.
• Able to communicate effectively with and influence team members from other functions. Demonstrate potential for leadership as manager and as technical lead.
• Fully understand processes and be able to represent Stats on process initiatives.
• Begin to establish research areas within pharmaceutical development.
• Ability to make decisions for assigned studies and knows when to seek guidance.
• With occasional supervision and guidance from senior departmental staff, including project lead statistician, or Therapeutic Area lead biostatistician. Experienced incumbents may mentor (Sr) Biostatisticians in their duties.