We are seeking an experienced oncology biostatistician.

Responsibilities:

  • Serve as a biostatistics expert for research, design, analysis, reporting and presentation of sophisticated statistical analyses and methods for clinical studies
  • Write or review statistical analysis plans and contribute to the design of clinical studies
  • Participate in the writing of clinical study reports and other regulatory submissions
  • Design or validate SAS computer programs that analyze and report clinical trial data
  • Conduct exploratory analyses of clinical trial data
  • Interface with vendors (CROs) to manage timelines, milestones, and finance
  • Review DMP, CRF design and other DM documents
  • Manage all aspects of clinical projects to ensure that they have an optimal opportunity to meet their objectives while complying with regulatory rules and guidelines
  • Represent company in interactions with regulatory bodies

Requirements:

  • Advanced Degree preferred (MA, PhD), Statistics or Epidemiology or Math with a concentration in statistics
  • At least 5-8 years industry related (Pharmaceutical, Biotech, CRO) biostatistics experience or equivalent
  • Experience in designing oncology clinical trials
  • Experience in analyzing results of oncology clinical trials
  • Experience in constructing technical programming specifications and producing validated SAS programs
  • Adept at outsourcing and managing biostatistical services provided by CRO’s and/or contractors
  • Proficient with strategizing, planning, monitoring and problem solving 
  • Experience being a leader able to contribute to the statistical aspects of clinical protocol design, data interpretation, review and reporting of results for multiple studies and projects
  • Excellent knowledge of applied statistical methodologies
  • Excellent knowledge of progression-free survival and other cancer clinical endpoints
  • Excellent knowledge of ICH guidelines and good programming practices
  • Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH and SAS/STAT
  • Excellent knowledge and experience with CDISC requirements
  • Familiarity with medical coding dictionaries (WHO-DRUG ®,  MedDRA )
  • Excellent written, verbal and interpersonal communication skills
  • Strong organizational and analytical skills