Director Biostatistics

Real World Evidence Sciences Cambridge, Massachusetts Raleigh-Durham, North Carolina Plymouth Meeting, Pennsylvania


Description

Position at ConcertAI

Company Overview

ConcertAI’s mission is to accelerate insights, advance research, and improve patient outcomes in oncology and across life sciences. ConcertAI’s leading real-world evidence, AI technology and software-as-a-service solutions support healthcare decision-making across clinical research & development through commercialization. Top biopharma sponsors, clinical research organizations, healthcare providers and institutions rely on ConcertAI’s evidence-generation and digital transformation capabilities to advance precision medicine and medical innovation.

 

ConcertAI has emerged as one of the fastest growing AI health tech companies backed by industry-leading private equity companies: SymphonyAI Group, Declaration Partners, Maverick Ventures, and AllianceBernstein PCI.

 

Role Summary

ConcertAI is a fast-growing healthcare research organization, leading the market in oncology healthcare data analytics. Our dynamic, fun, and highly experienced team is looking for an Associate Director to join us. As a Director in the Real-World Evidence Sciences (RWES) business unit, you will be responsible for statistical oversight of studies conducted using ConcertAI’s industry-leading and cutting-edge healthcare data resources. Our team operates in a cross-functional environment with representatives from other functions such as our Scientific Management, Data Curation, Data Products, and Data Science business units.

 

As a Director on our team, you will be reporting to a Senior Director in the RWES business unit and will provide high quality analyses and summaries for health economics and outcomes research (HEOR) and regulatory RWE retrospective studies. Your responsibilities will involve establishing clinical and statistical standards, as well as overseeing their implementation on research projects dedicated to improving our understanding of the patient journey and treatment outcomes in the oncology space, as well as making meaningful impacts on patients' lives. Directors may supervise Associate Directors or a team of other statisticians such as Statistical Analysts or Senior Statistical Analysts. Directors will also participate in data quality control and review results. The Directors will contribute to, and support, corporate goals to progress the company’s portfolio of products.

 

Responsibilities

  • Serves as a client facing, go to market (GTM) role on the Biostatistics team; develops a suite of offerings and GTM strategy related to open and closed claims linked to EMR, studies based on access to source imaging linked to EMR, and predictive analytics capabilities, among others.
  • Consults on the development of scopes of work including project budgets and timelines related to biostatistics and data management.
  • Reviews study proposals for appropriateness of research design, sample size, planned analysis, and timelines.
  • Facilitates problem solving exercises with other teams such as Project Managers, Principal Investigators, and other scientific staff to address project specific challenges.
  • Oversees the development of Statistical Analysis Plans (SAPs) and study protocols to define eligibility criteria, study measures, and statistical methodologies.
  • Creates or defines data structures by determining patient or disease cohorts, establishing study samples, and structuring data files according to research objectives and study design.
  • Directs the preparation of analysis-ready data and provides guidance on standard processes and the use of best practice documentation.
  • Supervises the quality control checks of data for anomalies, frequency, and distribution of data points for accuracy and consistency; helps determine root causes of errors, recommend solutions, and resolve data issues through queries and programming scripts.
  • Joins client meetings to support project teams and engage in conversations with the client associated with statistical methodology or analytical decisions.
  • Manages Associate Directors and indirectly their statisticians or a team of statisticians.
  • Tracks the biostatistical and data management components of study progress for direct reports to ensure timely completion of project milestones.
  • Assists in hiring, training, and mentoring staff, and conducts personnel evaluations of direct reports in accordance with standard ConcertAI processes.
  • Informs the strategic direction for Biostatistics and manages the tactics to implement the vision.
  • Delivers results for the Biostatistics team including revenue, gross margin, and other relevant key performance indicators (KPIs).
  • Identifies and implements initiatives to improve operational efficiency within the Biostatistics team in collaboration with the RWES Operations team.
  • Follows company policy and procedures regarding quality control, data security, and the ethical conduct of research involving human subjects, as well as the provisions of the HIPAA security and privacy rules.
  • Participates in other projects as assigned including statistical support roles and contributing to internal initiatives.

 

Requirements

  • Doctoral degree and four years of related programming and statistical experience, or Master’s degree and seven years of related programming and statistical experience with an area of study in quantitative science such as Statistics, Biostatistics, Analytics, Biometrics, Econometrics, Psychometrics, Operations Research, Engineering, or Data Science.
  • Background leading scientific research studies including overseeing design and methodology, data analysis, and statistical programming using patient-level datasets.
  • Expertise with SAS and its applications using healthcare data, such as claims or electronic medical records, or patient-reported outcomes.
  • Expertise with a second programming language such as SQL, R, Python, or another language.
  • Expertise using statistical methodology and advanced mathematical concepts such as ANOVA, linear regression, mixed models, time-to-event analyses, correlation analysis, sampling theory, analysis of categorical data, and appropriate transformations and permutations.
  • Ability to collaborate on multiple projects and deadlines, establish priorities for work activity, and solve practical problems.
  • Exceptional verbal and written communication skills with a proven ability to clearly and convincingly present information to a wide range of internal and external audiences.
  • Experience overseeing and implementing version control and peer coding review best practices.
  • Aptitude for understanding and applying best practices from documents such as safety rules, operating and maintenance instructions, procedure manuals, and correspondence. 
  • Familiarity with basic productivity software (e.g., Microsoft Excel, Microsoft Word, Web Conferencing Applications).
  • Detail-oriented, highly motivated, results-driven, and flexible to work in a scaling environment

 

Particular consideration will be given to applicants with the following qualifications:

  • Proficiency with a third programming language such as SQL, R, Python, or another language.
  • Prior supervisory roles with responsibilities involving hiring, training, and mentoring staff.
  • Prior experience managing or leading leaders of people.
  • Experience managing client relationships during the business development and execution phases of a project lifecycle.
  • Research history within the oncology space related to one or more specific solid tumor types, or to hematological malignancies.
  • Working knowledge of external control arms or other use cases of real-world evidence to support regulatory decision-making.
  • Understanding of FDA regulatory requirements, ICH guidelines, and GCP.
  • Publication track record.

 

Learn More About ConcertAI

Our team at ConcertAI is dedicated to transforming healthcare decision-making through the application of RWE and AI to improve patient outcomes. We work in a fast-paced, dynamic, high-performing culture where diversity, collaboration, and innovation are valued. Join us on our quest to create a world free of disease. Learn more about ConcertAI at www.concertai.com , or follow us on LinkedIn. 

 

EEO

ConcertAI provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.