Biostatistician

Paris, France

The right candidate will partner with senior management, clinical development team including medical, clinical operations, translational, and other scientists to support early clinical development for Hematology/Oncology. The statistician will provide expertise in the design and execution, of clinical protocols, case report forms, statistical analysis plans, statistical analysis, and interpretation of results (preparation of end of cohort meetings, DSMB meetings).

She/he will collaborate in the preparation of clinical study reports and will provide statistical expertise on regulatory submissions and ensure the quality and appropriateness of submission deliverables (especially for phase 1&2 clinical trials). She/he will support the development of innovative and efficient plans for developing new medicines in a variety of cancer indications. She/he will review scientific literature, promote innovation, efficient design and quantitative decision-making within research and in partnership with other lines, reducing the time and cost of drug development.

Published on December 04, 2019

Responsibilities:

  • Build and develop a high performing team
  • Provide strategic oversight for biostatistical analysis
  • Provide statistical expertise in design of clinical development plans, clinical study protocols, analysis, and clinical study reports
  • Work closely with clinical operations and medical to support clinical study planning and execution
  • Perform simulation studies to explore the statistical operating characteristics in study design phase including innovative/adaptive designs
  • Write the statistical section in clinical protocols
  • Provide statistical expertise in the SAP and table, listing, and figure shells
  • Review programming specifications and derived datasets
  • Perform or review statistical analysis as defined in SAP
  • Contribute to cross-functional decision making on study design, endpoints (DLT evaluation, global safety profile, detection of signal), data collection, and analysis strategies, ensuring alignment with study objectives
  • Support QC of CRO activities to include UAT, Query management, Data review, DM documentation such as DMP, DVS, edit checks, coding, lock process
  • Interpret study results and write (or at least QC and review) statistical summary reports of study results
  • Independently identify and anticipate technical or data related issues arising in the design, conduct or analysis of clinical trials or other scientific research, and approve and implement alternative analysis strategies or other recommendations to address these issues
  • Partner with Translational Sciences group to develop and optimize biomarker assays, assess and optimize biomarker technology platforms, including technology platform due diligence.
  • Provide statistical expertise and guidance on the scientific and statistical strategy and execution of the strategy for the development of candidate predictive biomarker(s).
  • Support Regulatory in preparations for interactions with regulatory agencies
  • Contribute to the development, implementation, maintenance and evolution of the department systems and processes involved in the collection, review and analysis of clinical and translational data
  • Evaluate appropriateness of available software for planned analyses and ascertain needs for potential program development of novel statistical methodology
  • Strong technical skills, including but not limited to general linear and mixed models, survival analysis, high-dimensional data analysis, bayesian statistics, design of experiments, statistical methods for biomarker assay development and validation and joint evaluation of therapies for efficacy and safety with biomarkers for prediction and classification.

Requirements:

  • PhD degree in statistics or biostatistics
  • At least (5) 10 years of experience in oncology pharmaceutical development and applied statistics/statistical consulting required
  • At least 5 years of management experience leading biostatistics and programming groups
  • Experience in computational simulation, analysis of biomarkers, and Bayesian statistics.
  • Knowledge of FDA, and EMA regulations, and ICH guidelines for drug development pertaining to statistics
  • Experience with the relevant regulatory requirements for data management and supporting SOPs
  • Experience in use of commercial clinical data management systems/EDC products (e.g. RAVE, Inform, TrialMaster, etc) and other software in data visualization (e.g. Spotfire)
  • Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies
  • Familiar with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
  • Familiar with SAS. Knowledge of R would be a plus.
  • Demonstrated ability to work independently, handle multiple priorities within timelines, and collaborate with other functions to resolve issues and improve efficiency
  • Excellent inter-personal skills in management, collaboration, and communication to managers, colleagues, team members, CROs, external statistical / medical experts, and external collaborators
  • Enthusiastic, passionate about bringing important new therapies to patients with cancer, and willing to roll up his or her sleeves to do whatever it takes while building the right team of outstanding statistics and data management professionals.

Please be sure to quote the reference Cellectis – Biostat, in the subject line of your email application.