Associate Director, Statistical Programming (Remote)
ASSOCIATE DIRECTOR, STATISTICAL PROGRAMMING (Remote)
The Associate Director, Statistical Programming oversees primarily all SAS programming activities for one or more Medical Affairs programs to ensure timely and accurate delivery of data analysis, data mining, epidemiology-related analyses, TLF generation for post-marketing clinical trials, use of clinical trial data to inform reimbursement strategy and HTA required analyses, real world evidence, quality of life data, and reporting in collaboration with partners in Medical Affairs. Independently provides strategic programming input to drug development planning, including feasibility assessments, development plans, and cross-study programming efficiencies. Works closely with Data Management and Biostatistics to contribute in providing overall Biometrics leadership, direction, and consulting as it relates to the reporting of clinical trials in support of all Phases of clinical development and regulatory submission programs. This individual is also accountable for timelines and quality of programming deliverables by providing oversight of the work performed by CROs, managing external (and/or internal) programming resources, or performing the work themselves, as needed.
This position reports to the Senior Director, Statistical Programming. The successful candidate will be a strategic leader and a hands-on individual contributor, with a proven track record of supporting complex drug development programs, as well as strategic manager of internal and external partners.
Essential Duties and Responsibilities:
- Provide statistical programming expertise and general input into GBT Medical Affairs programs
- Represents programming in core project team meetings on operational and strategic decision-making related to assigned projects
- Collaborate with counterparts in Medical Affairs, Biostatistics, Clinical Data Management, Clinical Science, Clinical Operations, and Clinical Programming and provides Biometrics leadership and provides support for a broad range of activities in the Medical Affairs programs
- Lead Medical Affair Statistical Programming organizational strategy and manages internal and CRO resources as needed
- Provide input in the selection of CROs, manage CRO programming activities for clinical trials
- Ensure company business needs and partner organizations are satisfied within agreed-upon timelines with respect to statistical programming activities and the exchange of data sets for Medical Affairs programs
- Contributes to establishing and driving strategy for resourcing, processes and standards to achieve quality and maximize efficiency
- Review and interpret Statistical Analysis Plans and provide comments for assigned projects.
- Review key study documents produced by other functions (e.g: CRFs, data management plans, SAPs, clinical study reports, etc.)
- Provide GBT programming infrastructure and processes that meet regulatory GCP standards
- Stay abreast of current regulatory environment focusing on CDSIC submission standards
- Lead development of complex, technical solutions for projects or business needs
- Independently bring technical solutions to the programming group
- Cultivate and maintain good communications and working relationships with internal/external functions
- Develop, revise, and maintain SOPs and WIs for the programming group, as needed
- Carry out all activities according to SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP). Ensuring adherence to programming guidelines
- Supervise the activities of junior and contract statistical programmers and carry out line management responsibilities
- Bachelor’s degree or equivalent experience with a computer science, mathematics, or statistics major preferred. In addition, must have a minimum of 7+ years of experience in the biopharmaceutical (or CRO) industry as a statistical programmer, and must have excellent SAS programming skills and experience programming datasets utilizing CDISC standards
- Must be able to work independently
- Outstanding communication skills (written and verbal)
- Strong leadership skills
- Input into and negotiate statistical programming timelines
- Ensure that timelines are adhered to coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget
- Exceptional hands-on SAS programming skills and expertise in the development and implementation of statistical programming procedures and processes in a clinical development environment
- Must be solution-oriented and educate study team members regarding the best use of programming resources
- Able to collaborate effectively with internal and external study management teams to meet project timelines with high quality standards
- Thorough knowledge of metadata and CDISC standards
Fit with GBT culture:
- Ability to build strong relationships with co-workers of various backgrounds and expertise
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
- Values-based leadership consistent with GBT's Core Values
- Excitement about the vision and mission of GBT
NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.