Director, Biostatistics

Responsibilities

• Build and lead a high-performance team of biostatisticians with expertise in various aspects of statistics, clinical trial design, and data analysis.
• Provide expert conceptual and methodological leadership and collaborate with stakeholders through the design and conduct of retrospective validation studies.
• Lead development on statistical analysis plan (SAP) for Tempus sponsored interventional and observational studies. This will include sample size and power calculations, and propose accurate and efficient statistical methodologies.
• Drive the planning and delivery of key analytical or clinical components of regulatory submissions, including but not limited to Q-subs, TAs, PMAs, and sPMAs.
• Participate actively in interactions with regulatory authorities, supporting Tempus’ regulatory affairs team.
• Represent Biostatistics in key regulatory meetings.
• Collaborate with data scientists, laboratory scientists, the medical team, technologists and the regulatory team on study design, planning, data preparation, programming, analysis and presentation of results.
• Produce high quality and detailed documentation for all projects in collaboration with other biostatisticians and data scientists.
• Independently work on complex problems, and select and adapt novel methods as appropriate.
• Stay updated on the latest methodological advances in real world data studies and clinical trials.

Requirements

• Ph.D. or Masters Degree in Biostatistics, Statistics, or a related field with 7+ years (Ph.D.) / 9+ years (MS/MA) relevant industry experience.
• Proven experience working with Real World Data and its applications in clinical research.
• Experience developing SOPs to document departmental processes for biostatistics.
• Demonstrated management skills; ability to manage the work of Ph.D./MS level biostatisticians, and have developed training for junior statisticians new to the industry.
• Experience working with other groups involved in clinical research, such as Statistical Programmers, Clinical Operations, Data Managers, etc.
• Thorough understanding of statistical principles and clinical experiment methodology.
• Computational skills using R, and/or SAS, especially relevant statistical tools and packages.
• Able to work in a multi-disciplinary team setting and employ a team approach to decision making.
• Experience in time to event analysis and methodology.
• Experience working in oncology and/or cardiology clinical trials and/or experience with the analysis of RWD studies (e.g. using claims, EHR or registry data sources).
• Experience with machine learning techniques and the advantages and disadvantages of different approaches, especially with respect to predictive and prognostic algorithms in medical research.
• Experience in cancer genetics, immunology, molecular biology, or ECG prediction model.
• Self-driven and works well in interdisciplinary teams.
• Collaborative mindset, an eagerness to learn and a high integrity work ethic.
• Sharp attention to detail and passion for delivering high quality and timely analytics deliverables.
• Able to effectively present research results to study team and other collaborators, including results interpretation and drawing appropriate inferences based on study design/statistical methods as well as assessment of study limitations.

Qualifications

• Extensive knowledge of time to event analysis and methodology.
• Experience working in oncology and/or cardiology clinical trials and/or experience with the analysis of RWD studies (e.g. using claims, EHR or registry data sources).
• Experience with machine learning techniques and the advantages and disadvantages of different approaches, especially with respect to predictive and prognostic algorithms in medical research.
• Experience in cancer genetics, immunology, molecular biology, or ECG prediction model.
• Self-driven and works well in interdisciplinary teams.
• Collaborative mindset, an eagerness to learn and a high integrity work ethic.
• Sharp attention to detail and passion for delivering high quality and timely analytics deliverables.

Benefits

• Full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.
• For remote roles open to individuals in unincorporated Los Angeles – including remote roles- Tempus reasonably believes that criminal history may have a direct, adverse and negative relationship on the following job duties, potentially resulting in the withdrawal of the conditional offer of employment: engaging positively with customers and other employees; accessing confidential information, including intellectual property, trade secrets, and protected health information; and appropriately handling such information in accordance with legal and ethical standards.

Pay

CHI: $180,000-$240,000 USD
NYC/SF: $190,000-$260,000

Schedule

Tempus offers a flexible schedule to accommodate the needs of our employees.