Job Details

Executive Director, Biostatistics and Statistical Programming Process and Infrastructure (BSPPI)

Loxo Oncology, Inc.
Stamford, Connecticut, United States

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. 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 Executive 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. This individual will work closely with the Biostatistics leadership team, Lilly biostatistics and data management to establish best practices, processes and efficient integrated handoffs from data and analysis perspective. The Executive 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 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 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.

currently anticipates that the base salary for this position level could range from between $186,000 to $272,800 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.

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:

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

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