Associate Director, Biostatistics
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
This is a great opportunity for an Associate Director, Biostatistics to join us and provide leadership and oversight of the Biostatistics department. The focus will be to provide leadership for the department focusing on strategic client partnerships/portfolios that are considered complex in nature, while increasing efficiency and quality of Biostatistics services to improve performance, utilization, delivery, and profitability. This key leadership role is responsible for providing technical leadership and biostatistical support to Clinical Development through the design and conduct of clinical studies; review and accuracy of clinical data; the evaluation, interpretation, and reporting of study results. The Associate Director must possess the ability to plan, direct and coordinate a variety of specialized and complex development projects, must have knowledge of clinical design of experiments, clinical data management and programming tools, and ability to interpret results from clinical studies. The Associate Director should have the ability to help implement new initiatives and assist in strategic planning. The Associate Director directs the activities of biostatisticians.
From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical and biotechnology companies, with our patients at the center of all that we do, we help to accelerate the development of drugs that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success.
- Develops department Standard Operating Procedures (SOPs) and guidelines, in collaboration with Statistical Programming, promoting standardized and consistent processes to maximize the efficiency of the department.
- Provide supervision and oversight to biostatisticians and programmers.
- Ensures that the Biostatistics department meets timelines, provides high quality deliverables, complies with contractual project requirements, and SOPs, and conducts projects within budget.
- Responsible for staff development, training, and retention. Oversees development of direct reports by setting goals, managing performance, evaluating, and monitoring training needs, supporting development plans, mentoring, and coaching.
- Facilitates succession planning and maintains a Biostatistics staff with diverse skills, abilities, and competencies meeting the business needs of the Biostatistics department.
- Makes recommendations for, and participates actively in hiring, onboarding, transferring, and terminating staff.
- Maintains a good working knowledge of clinical drug development, ICH, SDTM, ADAM, and TLFs, and other regulatory guidelines, and biostatistics to effectively serve as a Biostatistical department mentor. Develops and provides training for Biostatistics associates.
- Provide consultation to biostatisticians on complex statistical issues and work with study teams and scientific collaborators to provide strategy and high-level input to study design, research initiatives and other relevant topics.
- Provide regular feedback to leadership on the progress of projects, timelines, and deliverables, as well as challenges and accomplishments.
- Prioritizes activities across Biostatistics projects and facilitates mutually beneficial resolutions to project conflicts between groups or individuals, creating solutions to address business and operational challenges.
- Provide statistical input on clinical electronic data capture (EDC) design as well as assist data management with defining internal and external edit checks to ensure data are collected in a manner which satisfies any interim and/or final study analyses.
- Ensure the appropriate and accurate application of statistical methods to study design and analysis. • Supports the assignment of, or directly assigns Biostatisticians to projects in a manner which keeps associates at their utilization goal, and which matches associates to projects appropriate to their skills, training, and experience.
- Conducts senior review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documents.
- Work collaboratively with other departments to optimize cross department functionality. • Establish and maintain positive relationships with industry clients that foster confidence, facilitate problem resolution and ensure repeat business
- May participate in or lead departmental or corporate initiatives.
- Supports business development activities.
- Performs other work-related duties as assigned.
- Minimal travel may be required.
Demonstration of Tempus Compass Values:
Consistently strives to demonstrate the following Tempus Compass values:
- Recognizes that the team is always stronger than the individual.
- Seeks to inspire others by demonstrating consistently strong performance.
- Treats people with respect regardless of role or point of view.
- Listens well and seek to understand before reacting.
- Provides candid, helpful, and timely feedback to colleagues.
- Demonstrates curiosity about and contributes effectively to areas outside of their specialty. • Keeps the bigger picture in mind when making decisions.
- Never stops learning.
- Questions assumptions and offers suggestions for improvement.
- Focuses on results rather than process and seeks to minimize complexity when process is required. • Identifies and addresses root causes, not symptoms.
- Demonstrates poise in stressful situations.
- Strives to always do the right thing.
- Questions actions that are incongruent with Highline Sciences values.
- Graduate degree, or equivalent, in biostatistics or related discipline.
- 7+ years of experience in clinical trials or equivalent combination of education and experience with increasing levels of responsibility.
- Previous progressive management experience and demonstrated leadership ability. • Extensive knowledge of the drug development process, regulatory requirements, and relevant guidelines. • Ability to apply knowledge of statistical design, analysis, and programming techniques used in clinical trials. • Ability to read, write, speak, and understand English.
- Excellent communication, presentation, and interpersonal skills, with an ability to inform, influence, convince, and persuade.
- Experience with early phase oncology and regulatory submissions
- Extensive leadership with larger integrated documents, leadership of committees and/ or substantial reporting for publication.
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.