Penfield Search Partners
Contact: Jessie Schlomann – jschlomann@penfieldsearch.com
Hybrid role – Remote with some travel to Boston
Job Description:
- Serve as leader, expert, mentor and manager of group supporting translational and exploratory statistical analyses in support of company R&D assets across Therapeutic Area Units (TAUs)
- Drive collaborations with biomarker, translational and clinical scientists across TAUs to enable biomarker development strategies for early clinical development decision making
- Strategize and prioritize opportunities for Quantitative Sciences group AI/ML, RWE, advanced analytics and modeling to maximize impact on the organization
- Lead implementation of strategies, goals, and priorities for the Quantitative Sciences group within the broader SQS organization
- Oversee and ensure achievement of all deliverables and milestones for programs across TAUs
- Align analytical efforts and resource allocation with TAU strategies, portfolio priorities, partner lines work, and with Digital and Technology
- Manage, mentor and grow interdisciplinary team of biostatisticians, computational scientists and data scientists to integrate translational and early clinical assets to advance R&D programs
- Promote statistical innovation and collaborations in data analytics for exploratory biomarker research representing Quantitative Sciences group
- Develop and manage relationships with the external research community; serve as the scientific point person at meetings with KOLs, conferences, and industry events
- Provide statistical leadership in the development and review of the study synopsis, protocol, statistical and exploratory analysis plans, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables within and across TAUs as appropriate
- Provide strategic statistical input to feasibility assessments, development and submission plans, and defense of regulatory submissions across TAUs, including timelines
- Identify and interact with external statistical experts for issues related to design, methodology and results as the primary contact and spokesperson
- Increase efficiency of the Statistics function through development of standard and/or innovative analysis methodology, data presentations, and sharing of best practices
- Leverage scientific expertise for strategic statistical leadership by providing recommendations and statistical consultations to management
- Monitor and contribute to industry advances in statistical methods to optimize study designs and statistical analyses techniques, and lead implementation of innovative approaches within and/or across TAUs as appropriate.
- Demonstrate leadership of TAU, BU, or SQS function or specialty area in preclinical / clinical / translational
- Act as a cross functional leader and accountable decision maker that has direct impact on R&D
- Define and contribute to strategic vision, mission and respective implementation for the promotion of SQS within TAUs, BUs, and R&D functions
- Identify opportunities and create delivery for DSI mission to make R&D business impact
- Be involved in mentorship, matrix or direct management of large team of SQS colleagues
- Be accountable for growth and development of SQS and DSI talent profile
- Show influential leadership both within and outside of company in area of expertise
Minimum Requirements/Qualifications:
- Applicant for this position should have degree in statistics/biostatistics or in other equivalent quantitative sciences (e.g., Applied Mathematics, related quantitative field) along with the following specific credentials: PhD with ~12+ years experience or MS with ~15 years experience
- Provide strategic leadership
- Mobilize high performance from teams
- Influence beyond SQS and DSI
- Knowledge of the pharmaceutical drug discovery and development process with a relevant track record of R&D hands-on work and leadership
- Experience in the early clinical stages of drug development.
- Expertise and track record of implementation of advanced statistical modeling across several TAUs
- Expertise in biomarker and outcomes instrument validation for clinical trial endpoint use
- Pragmatic leader with a focus on driving the teams using fit-for-purpose philosophy and a track record of creativity and innovation
- Track record of integrating discovery/medical and statistical best practices into translational and clinical research to improve reproducibility, efficacy, safety of the exploratory endpoints across phases of drug development
- Demonstrated ability to work collaboratively with research project teams in both preclinical and clinical development programs
- Ability to translate/explain complex statistical concepts to non-experts; ability to speak across disciplines of Quantitative Sciences umbrella: statistics, engineering, applied mathematics, computational biology, pharmacokinetic/pharmacodynamic modeling, and others
- Excellent communication and presentation skills
- Expertise in statistical programming, modeling and simulations
- Technical expertise across a TAU – understands the TAU strategy to lead and drive optimized methodology in drug R&D
- Leadership in TAU and functional methodology decision making to optimize the likelihood of drug R&D success
- Solid technical background in statistical and signal processing methods of analysis for imaging, physiological, sensor data
- Capability to create technical strategic vision and implement long-term innovation that is aligned with global regulatory and payer policies and trends
- Capability to create major technical and methodology projects and guide them to implementation across R&D
- The ability to establish external network to facilitate collaborations across industry, government, and academia
- Strong track record of scientific publications, both methodological developments as well as applied
- Track record of technical proficiency in hands data analysis and scientific programming using variety of languages such as SAS, R, MATLAB, python, Julia, C/C++