Career Opportunities

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by our goal of improving the lives of people living with cancer. We pursue this goal with a tenacity, focus, and commitment to excellence that defines who we are and how we work.

We seek dedicated, passionate, hardworking, intelligent, thoughtful, and authentic individuals who thrive within a collaborative and fast-paced environment and will bring their experiences, unique perspectives and problem-solving skills to the team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a meaningful difference in the lives of patients.

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Biostatistician

Location: South San Francisco, CA

Reports To:

Senior Director, Biostatistics

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

This position will serve as study statistician for Phase 1-3 oncology studies to support NDA submissions as well as coordinating activities with other functional groups to ensure timeliness and quality of study deliverables.

Roles and Responsibilities of the Position*

Assist data management staff in the design of case report forms; review of study database structures, data management plan, edit check specifications, and manual data review listing specifications; write additional data check specifications.
Develop and review statistical analysis plans, including the definitions of derived variables, structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports.
Direct and conduct statistical analyses and interprets results of analyses for assigned studies. Maintain consistent analytical approaches and reporting formats within and across studies.
Understand and utilize SAS as well as other statistical software packages. As needed, write programs to select/retrieve/manipulate/edit/analyze data.
Responsible for the accuracy and completeness of statistical analyses conducted for assigned studies. Research and apply new statistical procedures as needed.
Prepare statistical summary reports as needed. Write and/or review the statistical sections of protocols and clinical study reports. Review draft protocols and clinical study reports.
Document and archive analysis and programming work to ensure a complete audit trail. Create and maintain biostatistics files for each assigned study.
Establish and maintain effective working relationships with vendors and study teams, including data management personnel, statistical programmers, clinical research personnel and corporate partners.
Participate in study meetings as needed.

Required Qualifications and Background

MS or PhD in Statistics/Biostatistics or related field with 0-2 (with PhD) or 1-3 (with MS) years of experience in biotech/pharmaceutical industry or medical research setting as a statistician or statistical analyst
Oncology experience is highly preferred
Ability to work effectively in a cross-functional team setting
Able to collaborate effectively with internal and external study teams to meet project timelines.
Good interpersonal and project management skills are essential.
Excellent written and oral communication skills

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.