Assoc Dir Bio (DG)
Chicago, IL - Pharmaceutical & Biotech - Remote - Full time
Date Posted: 1/12/2024
Associate Director Biostatistics (Remote or Onsite/Hybrid)
Oncology, Phase I
Base Salary up to $190,000 plus bonus of 20%, plus stock
**Must have current Pharmaceutical/Biotechnology experience**
Top 10 Pharmaceutical company located in Chicago, IL is looking for an Oncology Biostatistician to provide scientific and statistical expertise for drug discovery or development strategies for assigned project in early stage oncology for the design, analysis, and reporting of scientific research trials and for interacting with regulatory agencies regarding the results of these activities. The Associate Director Biostatistics leads the development of scientific protocols ensuring they are scientifically sound and make optimal use of the data to be collected. Confirm research hypotheses and corresponding study designs are aligned with the project strategy, and meet scientific or regulatory needs. Ensures statistical methodology is appropriate and sound, consistent with the objectives of the scientific protocol.
Demonstrates extensive understanding of statistical concepts and methodologies. Proposes new and novel statistical methodological approaches leading to improvements in the efficiency and sensitivity of study results. Provides sufficient detail to allow programming implementation. Ensures that all the statistical analyses specified in scientific protocols and/or analysis plans are conducted appropriately.
SCIENTIFIC REPORTS AND PUBLICATIONS:
Show that study results and conclusions are scientifically sound, clearly presented, and supported by the statistical analyses provided. Prepares oral and written reports to effectively communicate results of clinical and scientific research to management, project teams, regulatory agencies, or individual investigators. Provides in-depth scientific statistical review for scientific reports and publications. Works collaboratively with members of multi-function teams to complete project deliverables per agreed timelines. Keeps management informed on important scientific statistical issues that may arise, in a timely manner. In collaboration with Statistical Programming, ensures that all programs meet analysis requirements, internal standard operating procedures, validation, and external regulatory requirements. Communicates with statisticians outside the company concerning technical issues, building external scientific contacts, fostering professional development, and promoting the reputation of the department. Effectively and persuasively presents statistical concepts, evidence, assessment of risks and impacts, and logical arguments to management, regulatory agencies, and scientists. Demonstrates an understanding of drug development principles for assigned projects. Represents Data and Statistical Sciences or Biometrics on assigned project team(s) to provide functional area input to compound drug development. Serves as a liaison between the project team and DSS or Biometrics to ensure timely communication of project team updates, proper statistical strategies, and alignment of priorities between the project team and functional area.
SUPERVISING AND MENTORING:
Mentors junior staff and other development partners with regards to statistical methodology and departmental operations. Participates in department seminars, short courses, and the publication presentation of scientific articles. Participates in departmental activities including recruiting, training/mentoring, research efforts, and cross-functional collaborations, as needed. Participates with DSS or Biometrics management in discussions with corresponding technical personnel from regulatory agencies and with investigators concerning proposed or ongoing studies.
In collaboration with Data Sciences, Statistical Programming and other partners, ensures data collection instruments are designed to capture protocol-specified scientific information and study databases (e.g., SAS, MS Access, Excel) are implemented such that short- and long-term project needs can be achieved. Oversees or partners in the development of data quality assurance checks, ensuring accuracy and consistency of data released for statistical analysis.
PhD in statistics or related field with 7-10 years or MS in statistics or related field with 10+ years of work experience in pharmaceutical development and applied statistics or statistical consulting required. Project lead experience required. High degree of technical competence and effective oral and written communication skills. Competent in experimental design, statistical modeling and inferential statistics; actively seeks to acquire knowledge in the use of new & novel statistical techniques and their biometric & biopharmaceutical applications. Pharmaceutical or related industry experience with clinical studies, including experience and understanding of drug development in the regulated environment preferred. Strong experience in Oncology is a must. Experience in Phase I clinical trials (early development) is highly preferred.
Please contact Darren Gutowski at firstname.lastname@example.org