Loxo@Lilly Manager/Senior Manager, Biostatistics in Helena, Montana
Loxo@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@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 Louisville, CO, Indianapolis, IN, New York City, NY, South San Francisco, CA, San Diego, CA, Stamford, CT, and Madrid, Spain.
The Manager/Senior, Biostatistics will work as a study statistician on a Loxo development. The Manager/Senior Manager, Biostatistics will work collaboratively with cross functional clinical and development teams including clinicians, clinical scientists, statistical programmers, data managers, regulatory and clinical operations professionals to plan, conduct, and analyze clinical studies of all phases. The Manager/Senior Manager, Biostatistics will perform ad hoc analyses and support statistical programming team in specification and verification of analyses.
Roles and Responsibilities of the Position:
Works as the study statistician collaboratively with statistical programmers, other biostatisticians, clinical research associates, clinical data managers and other development functions to meet project and study deliverables for statistical data analysis and reporting.
Ensures appropriate use and implementation of statistical methodologies
Interacts with and oversees statistical vendors as needed
Provide instructions for derivations and analyses to statistical programming to ensure quality of deliverables
Develop statistical programs as necessary to perform analyses, prepare data displays and verify the correctness of data and analyses
Help design data capture methods and select appropriate study endpoints for clinical programs
Contribute to development of policies, procedures, and standards within the biostatistics department
Required Qualifications and Preferred Background:
PhD with minimum 2-4 years OR master’s with minimum 4-6 years of experience in statistics/biostatistics/related field is required
Minimum 1 year of clinical development experience in the pharmaceutical/biotech industry is required
Knowledge of clinical trial design, drug development regulations pertinent to statistical analysis, and sound understanding of statistical applications for clinical trials is required
Proficient SAS programming skills and an understanding of CDISC models and standards are required
Oncology experience is preferred
Ability to plan, develop timelines, multi-task, and shift priorities rapidly to meet tight deadlines
Excellent writing, interpersonal and communication skills
Available locations for this role:
- South San Francisco, CA
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for the Manager level position could range from between $103,200 to $151,423 and that the base salary for the Senior Manager level positions could range between $118,700 to $174,137 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. This position will also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Loxo provides a comprehensive benefit program to eligible employees, including vacation, medical, dental and vision benefits; participation in a 401(k) plan; life and accidental death and disability coverage; parental leave benefits and employee discounts for certain items. The compensation described above is subject to change and could be higher or lower than the range described.
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.
This position’s work environment is in an office.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
*To perform this job successfully, an individual must be able to perform the role and responsibilities 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
Loxo Oncology, Inc. (“Loxo”) is committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process for positions at Loxo, please email firstname.lastname@example.org for further assistance. Please note, this email address is intended for use to request an accommodation as a part of the application process. Any other correspondence will not receive a response.