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Cambridge, MA

Posted: 01/09/2020 Employment Type: Direct Hire Job Category: Clinical: Biometrics Job Number: 2493

Job Description

Our client is seeking an experienced oncology biostatistician.

  • 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 finances
  • 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 / Qualifications:
  • 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 CROs 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

Meet Your Recruiter

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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