Sr. Advisor - Statistics (RWE)

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 151,500 - 244,200; Full time

Benefits offered by this job

401(k) pension

Vacation benefits

Comprehensive health benefits

Job summary

Initial Therapeutics, Inc. seeks a Clinical Project Statistician in Indianapolis, Indiana. The role involves developing clinical plans, statistical analysis of data, and communicating results effectively. Candidates must hold a Ph.D. in Statistics or a related field and possess strong statistical programming skills and interpersonal abilities.

Key responsibilities include designing studies, ensuring regulatory compliance, and providing insights on research methods. The anticipated salary for this position ranges from $151,500 to $244,200, with additional benefits and bonuses based on performance.

Qualifications

• Minimum 3 years of experience in Real World Evidence research.
• Competence in justifying selected statistical methods.
• Experience with regulatory submissions and collaboration.

Responsibilities

• Provide input on study protocol and design studies.
• Write reports and communicate results with team members.
• Understand disease states and enhance customer focus.

Skills

Statistical programming languages (SAS, R, etc.)

Interpersonal communication skills

Teamwork and leadership

Creativity and innovation

Problem-solving ability

Education

Ph.D. in Statistics or Biostatistics or Epidemiology or Computer Science

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Purpose

The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and other research colleagues. The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for clinical studies.

Primary Responsibilities

Statistical Trial Design and Analysis

• Provide input on study protocol, design studies and write protocols for the conduct of each study.
• Be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol and the statistical analysis plan, and conducting the actual analysis once a reporting database is created.
• Collaborate with data sciences in the planning and implementation of data quality assurance plans.
• Maintain currency with respect to statistical methodology, maintain proficiency in applying new and varied methods, and be competent in justifying methods selected.
• Perform peer‑review of work products from other statistical colleagues.
• Influence team members regarding appropriate research methods.

Communication of Results and Inferences

• Collaborate with team members to write reports and communicate results.
• Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one‑on‑one with key customers and presenting at scientific meetings.
• Respond to regulatory queries and interact with regulators.

Therapeutic Area Knowledge

• Understand disease states, competitive landscapes, and regulatory environment in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.

Regulatory Compliance

• Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.

Statistical Leadership and Teamwork

• Introduce and apply innovative methodology and tools to solve critical problems.
• Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions.
• Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions.

Minimum Qualification Requirements

• Ph.D. in Statistics or Biostatistics or Epidemiology or Computer Science with at least 3 years of experience in Real World Evidence research.

Other Information / Additional Preferences

• Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUGs, etc.
• Interpersonal communication skills for effective customer consultation.
• Teamwork and leadership skills.
• Technical expertise and application with working knowledge of experimental design and statistical analysis.
• Self‑management skills with a focus on results for timely and accurate completion of competing deliverables.
• Resource management skills.
• Creativity and innovation.
• Demonstrated problem‑solving ability and critical thinking.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

The anticipated wage for this position is $151,500 - $244,200. Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k) pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day‑care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.