Director, Biostatistics, Sarah Cannon Research Institute - Nashville, TN
Sarah Cannon Research Institute -Nashville - Nashville, TN

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JOB TITLE - Director of Biostatistics

POSITION SUMMARY: Reporting to Senior Director of Data Science, SCRI Services, the Director of Biostatistics, SCRI Services will serve as a key member of the SCRI Services Leadership Team and ensure that appropriate statistical techniques are used which ensure the scientific validity and overall quality of clinical trial results. The Director of Biostatistics, SCRI Services will lead all statistical analysis, contribute statistical input and represent the Biostatistics function of SCRI Services to external partners..

SCRI firmly believes in its mission to "advance therapies for patients;" therefore, SCRI considers it a priority to find the right leader for the Director of Biostatistics, SCRI Services position. This position will be critical to SCRI's success in the improvement of patient outcomes and the advancement of medical science. SCRI is looking for a strong business person who has proven to be exceptional in Biostatistics leadership.

The following are core areas of accountability / opportunity for the Director of Biostatistics:

  • Lead a team of Biostatisticians and SAS programmers in support of the overall business and ensure the Biostatistics team does the following;
  • Contribute to protocol development (including sample size calculation) & protocol/CRF review
  • Work collaboratively with SCRI scientists and authoring physicians
  • Work collaboratively with vendors and other external partners
  • Represent SCRI to external partners in a professional manner
  • Coordinate the development of randomization schema
  • Coordinate & develop statistical analysis plans
  • Coordinate & perform data review & statistical analyses
  • Coordinate and produce statistical outputs
  • Write statistical sections for integrated reports and statistical reports
  • Advise DM with respect to database design, validation checks & key data
  • Provide leadership to develop and implement SCRI Biostatistics process initiatives on a global level;
  • Assist in overseeing and establishing quality performance indicators to ensure all statistical processes work in harmony to accomplish SCRI Services' objectives and goals
  • Set and maintain professional statistical standards
  • Provide an oversight of all statistical and SAS programming deliverables
  • Maintain & archive program documentation - both electronic & paper - in an appropriate manner
  • Actively participate in meetings / presentations with the regulatory authorities and other professional associations
  • Understand and apply regulatory guidelines/developments and industry standards/best practices on statistics and SAS programming
  • Keeps management abreast of issues and progress on all assigned projects
  • Contribute to internal process development and improvement
  • Maintain thorough and up-to-date working knowledge of GCP's and regulatory requirements relating to clinical development and safety compliance with ethical, legal and regulatory standards;
  • Mentor members of the SCRI Services team to ensure successful and strategic execution of SCRI Services projects;
  • Maintain statistical / clinical / therapeutic acumen in clinical research through education, programs, lectures and publications;
  • Collaborate with all functions to earn their respect as a trusted and value-driven business partner; and

  • Advanced degree in Biostatistics or Statistics required: MSc minimum, PhD preferred
  • At least 10+ years of biostatistics in a regulated clinical research environment ( pharmaceutical / biotechnology / CRO) required
  • International experience preferable
  • In depth and thorough understanding of the clinical research and drug development, and requirements on regulatory submissions and compliance
  • Excellent broad knowledge in statistics including study design methodologies, categorical data analysis, survival analysis etc, and experience in the use of modeling and simulation to enhance clinical trial design and decision making.
  • Must be familiar with ICH guidelines, regulatory requirements and industry standards (eg CDISC) and best practices related to statistical and programming activities
  • Experience in major interactions/meetings and/or submissions with regulatory authorities (eg FDA, EMA)
  • Extensive and progressive management / leadership experience. Play an active role in mentoring and career development of statisticians and SAS programmers
  • Contribute to resource planning activities - plan resource and activities for projects assigned, and to corrdinate and assist statistical staff in their work where appropriate
  • Excellent teamwork skills placing emphasis on supporting the goals of the group
  • Strong hands-on experience and knowledge with SAS and other statistical software
  • Ability to work with within deadlines
  • Ability to manage multiple protocols and participate on multiple project teams simultaneously
  • Provide statistical advice and consultancy and/or any related services/training required within SCRI or by sponsors
  • Strong attention to detail
  • Excellent organizational, time management and problem solving skills
  • Outstanding communication and presentation skills
  • Absolute integrity, honesty, reliability and passion / enthusiasm about advancing therapies for patients.
  • Experience in oncology strongly desirableCross-cultural awareness