Graduate degree in Epidemiology, Biostatistics, or related field, with a PhD preferred., 15+ years of experience in epidemiology or related fields, including oncology., Expert knowledge of epidemiology, statistics, and real-world data study design., Proficiency in programming languages such as R, SAS, or Python..
Key responsibilities:
Design and analyze external control and hybrid studies using real-world data.
Collaborate with cross-functional teams to develop study protocols and statistical analysis plans.
Lead research studies, interpret results, and communicate findings through publications and reports.
Contribute to the development of N-Power Medicine's real-world evidence platform.
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Syapse
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About Syapse
To achieve more precise care for every patient, we need to transform real-world evidence into insights that can directly impact care. At Syapse, that is real-world care.
It’s found in the way we empower healthcare organizations to work together in active, transparent partnerships, delivering complete patient insights to answer the questions that matter and then purposefully applying it at where patients receive care – driving real impact for cancer patients and beyond.
NPower Medicine aims to establish a new paradigm in drug development by reinventing the ‘how’ and transforming clinical trials through better integration with clinical practice, ensuring broader participation by physicians and patients. We are building an exceptional multidisciplinary team with diverse expertise spanning healthcare, engineering, technology and regulatory, and with people who share our core value of Empowering Community through generosity, curiosity and humility. We are working with urgency to bring better therapies to patients faster.
Position Overview
The Principal, Quantitative Sciences is a key leader in the Quantitative Sciences (QS) team and is responsible for ensuring that rigorous and fitforpurpose study designs and analyses are performed to meet NPM’s vision and product claims. Working with a multidisciplinary team, this role will have the opportunity to fundamentally change the “how” of oncology clinical development. This responsibility includes working in close collaboration with other QS experts, Clinical Science, Product, Abstractors and other cross functional partners to conduct next generation external control arms (ECAs) that integrate retrospective and prospective realworld data with single arm and randomized clinical trials. Through this collaboration, the Quantitative Sciences leader also works crossfunctionally to develop and ensure adherence to appropriate processes for data collectioningestion, harmonization, standardization, quality control, management, analysis, reporting and publication. Quantitative Sciences plays a critical role in supporting our health system and life science partners, as well as our product portfolio.
This position is remote within the United States.
Role Objectives and Responsibilities
In collaboration with QS leaders, builds expert capabilities in prospective ECAs and hybrid controls combining retrospective and prospective real worlddata with single arm and randomized controlled trials.
Provides expertise for developing statistical methodologies that mitigate, observed and unobserved confounding, selection, and measurement bias in external and hybrid controlled studies.
Designs, implements, interprets, reports and publishes the results of retrospective and prospective observational research studies that demonstrates the utility of this data for life science partners.
Guides and mentors internal teams on novel methodologies, best statistical practices, innovative clinical trial designs, statistical inference, and reporting statistical results.
Collaborates with the Data and Technology cross functional partners to define data requirements, models and data collections processes to enable next generation ECAs.
Contribute to developing NPower Medicine’s realworld evidence generation platform, in alignment with the company’s byprotocol, prospective realtime registry data.
Help translate the perspectives and requirements of FDA and regulatory agencies around external controls to inform NPower Medicines data capturecollection and platform requirements
Asks the right scientific questions, ideates and makes recommendations on fitforpurpose data and analytics solutions.
Leads or supports research study design and endtoend delivery, in particular:
Study scoping, including sample size calculations and identification of data needs.
Design elements, and approach to bias mitigation in the design and analysis phases.
Development of study protocols and statistical analysis plans.
Leads or supports the execution of the analysis plan, including the development of adjacent algorithms and other scalable tools.
Leads the communication of novel methodology developed in the course of the study. Coauthors communications of study results in peerreviewed publications, presentations, and health authority reports.
Participates in internal, crossfunctional discussions on data and platform strategy, and workflow development.
Additional duties and responsibilities as required.
15+ years of experience with a Bachelor’s Degree, 12+ years of experience with a Master’s Degree and 8+ with a PhD in epidemiology.
Graduate degree in Epidemiology, Biostatistics or Related field, PhD with an emphasis in epidemiology preferred.
Knowledge of RWD study design and execution.
5+ years in oncology.
Expert knowledge of theoretical and applied epidemiology and statistics, including inferential methods for timetoevent analysis, survival analysis, and causal inference methods.
Expertise in design and analysis of externally controlled studies and hybrid controls including propensity score methods, endpoint measurement bias correction methods, and external patient borrowing bayesian abd frequentest methods.
Fundamental understanding of clinical and efficacy endpoints used in oncology development.
Experience collaborating with clinical, biomarker, and imaging scientists, to apply statistical methods to oncology drug development.
Extensive experience with programming in R, SAS, andor Python.
Strong communication and collaboration skills (including statistical consulting skills, and interpersonal skills).
Ability to work and collaborate in a fast paced, startup environment.
Entrepreneurial, credible and creative spirit capable of influencing stakeholders to advance the use of ECAs to inform Go noGo and regulatory decisions.
Excellent project management skills (including ability to manage scope and effectively delegate to other functions, staff, contractors and external vendors).
Excellent and autonomous drive for results (e.g., demonstrates interest and ability to learn new things, takes initiative, welcomes problems as challenges, proactively finds solutions to technical problems).
Generous, Curious and Humble.
Travel Requirements
Ability to travel may be required from time to time.
Pay Information
The expected salary range for this position is $220,000 $265,000 . Actual pay will be determined based on experience, qualifications, geographic location, and other jobrelated factors permitted by law. NPower Medicine (NPM) offers equity at hire as well as a discretionary annual bonus which may be available based on Company performance. This position is eligible for company benefits.
More About Us:
We are a missiondriven, wellfunded, rapidly growing company, eager to attract passionate professionals offering a highly attractive compensation package with a balanced and flexible work environment, competitive industry benefits as well as a 401K plan and other great company “perks.”
We are an Equal Opportunity Employer and value diversity at our company. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Covid19 Policy – The Company is committed to providing and maintaining a safe workplace, and to safeguard the health and wellbeing of our employees, families, visitors, and the community. While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary. We currently do not have mandatory COVID19 vaccination requirements for our employees and contractors, as the COVID19 public health emergency has ended. However, there are certain NPower Medicine employees and contractors who, based on their role, will be required to continue to follow our 2021 COVID19 vaccination and other requirements as mandated by NPower Medicine’s partners they serve. We reserve the right to modify or amend our corporate policy at any time.
Applicants must be currently authorized to work in the U.S. on a fulltime basis. The Company will not sponsor applicants for work visas.