Associate Director/Director, Biostatistics and Statistical Programming Process and Infrastructure (BSPPI) in Columbia, South Carolina
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 Associate Director/Director, Biostatistics and Statistical Programming Process and Infrastructure (BSPPI) will play a key role in modernizing the Biostatistics Department by assessing, improving, and managing its standards, infrastructure, and processes. The Associate Director/Director, BSPPI will work closely with the Loxo@Lilly Biostatistics leadership team, Lilly biostatistics and data management to establish best practices, processes and efficient integrated handoffs from data and analysis perspective. The Associate Director/Director, BSPPI will have an opportunity to influence best practices and innovative processes cross functionally to enable agile drug development in the context of an exciting and growing oncology portfolio.
Roles and Responsibilities of the Position:
Processes: Collaboratively lead assessment, implementation, and management of lean process development and associated documentation for biostatistics and statistical programming
Infrastructure: Partner with leads from interfacing cross functions such as Data Management and IT across Loxo@Lilly and Lilly to analyze and continuously improve the computing infrastructure that includes statistical computing environment and standard software utilities
People: Develop collaborative relationships with relevant functions within Loxo@Lilly and Lilly by leading/participating in cross functional initiatives to bridge the differences in standards, processes, and infrastructure.
Standards: Lead the development, improvement, and adaption of standards for statistical analysis documents, SAS and R programs, TFLs, and SDTM and ADaM datasets. Keep abreast with industry and regulatory trends related to biostatistics and statistical programming.
Technology: Introduce/develop breakthrough and incrementally innovative technical capabilities to ensure optimal operation of Biostatistics department.
Required Qualifications and Preferred Background:
Bachelor/Master’s/PhD Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields with a minimum 7-10 years Pharmaceutical/Biotech data science, programming and/or statistics experience is required
Experience in analyzing, designing, developing, and managing the change of implementing innovative solutions is required
Knowledge of SAS programming language and familiarity with macro development is required
Knowledge of programming languages in addition to SAS such as R and Python, and programming tools used in clinical research and drug development is preferred.
Solid knowledge of the drug development process, interaction of statisticians and statistical programmers, and experience in complex technical projects is required.
Familiarity with regulatory guidelines, CDISC standards, biostatistics and statistical programming submission deliverables, and validation processes is required.
Excellent verbal/written and interpersonal skills including the ability to communicate and collaborate effectively in a cross-functional setting
Loxo Oncology, Inc. (Loxo) currently anticipates that the base salary for this position level could range from between $135,300 to $ 198,516 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 above. Further, Loxo reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.
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.
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 email@example.com 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.