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Principal Biostatistician

Cambridge, MA

Posted: 04/03/2019 Employment Type: Direct Hire Job Category: Clinical: Biometrics Job Number: 2323

The position serves as the primary statistical role within the clinical development team. The Principal Biostatistician is expected to provide broad statistical support, contribute strategically to project decisions with a focus on pre-study planning, protocol development, sample size / power calculations, Statistical Analysis Plan preparation/ review, data quality reviews, development of tables / listings / figures, preparation / mapping of clinical study data for regulatory submission. The Principal Biostatistician is expected to understand advanced statistical methods and to research complex and innovative statistical approaches (e.g, modeling and simulation, adaptive design / Bayesian statistics). The professional will participate in meetings and teleconferences and provide consulting, interpretive and analytical support to Clients.
Required Skills
  • Responsible for statistical analysis plans. Review and consult on CRF design and data quality.
  • Oversee execution (by internal staff, 3rd  party vendors, consultants) of statistical analyses, including tables, listings and figures [TLFs], preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries. Review and approve statistical results and conclusions.
  • Serve as the initial review of data to assure consistency of terminology, format and able to tabulate and/or provide figures to establish the congruence of the data with general established statistical principles
  • Work independently, or with other statistical team members or consultants, to develop effective statistical approaches.
  • Collaborate with clinical, medical and regulatory functions in protocols development (e.g., study design, endpoints, analysis methods).
  • Represent statistical function in team meetings
  • Provide general guidance on definition and documentation of key derived variables needed to support production of TLFs. Assure consistency of data collection and analysis across studies in a project. Assist review of analysis datasets that are quality controlled, sufficient to produce TLFs for reports, compliant with regulatory requirements, and consistent within a project.
  • Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs. Within area of control, update procedures or practices as needed to remain in compliance.
  • Promote innovative clinical trial designs and efficient analysis methodologies
Required Experience
  • Ph.D. in statistics or related discipline with at least 5 years of experience in the biotechnology, pharmaceutical or health related industries Or Masters degree with at least 8 years of experience.
  • Works independently, self-directed, high energy and strong work ethic. High degree of creativity, problem solving, latitude and attention to detail required
  • Ability to work in a small, fast-paced environment covering a range of activities from document creation to agency interactions as the need arises
  • Demonstrated strong project management, teamwork, and interpersonal skills
  • Knowledge and understanding of advanced statistical concepts and techniques applicable in clinical trials and drug development.
  • Knowledge of drug development, and biometrics-relevant FDA, EMA and ICH guidelines and regulations.
  • Excellent oral and written communications skills.
  • Expertise in statistical programming, modeling and simulations
  • Understanding of the drug discovery and development process, regionally and globally
  • SAS, R, Sample size calculation software

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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