The Manager Statistical Programming Oncology Early Development (OED) is a key member of the Data Management and Analysis department. This individual provides statistical programming oversight for OED clinical projects conducted by CROs. The Manager builds relationships and promotes collaboration across functions with internal colleagues. This individual is responsible for making recommendations related to CRO SOW, processes, and standards. This individual works to ensure data integrity for oncology first in human clinical trials up through clinical proof of concept.
· Manage CROs and other outside vendors for statistical programming activities for OED clinical trials as appropriate in relation to clinical trial data analysis needs.
· Oversees CRO SAS programming by providing ongoing review of activities and progress to ensure projects are delivered by the CROs on time with suitable quality.
· Provides CROs with input into the development of CRFs and database designs, and definitions.
· Oversees CRO effort related to derive data sets, submission data sets and programs, and analysis data set specifications. Oversee the CRO development of SAS programs for the creation of SDTM and ADaM data sets following CDISC standards for OED clinical trials and allowing for integrated data at AbbVie. Oversee the CRO development of SAS programs for the creation of Tables, Listings and Figures for OED clinical trials.
· Ensure that appropriate concepts and techniques relevant to the pharmaceutical industry are implemented for OED clinical trials. Responsible for monitoring regulatory guidance and industry best practices related to output design and programming conventions to allow for a seamless transition of work internally for programs that meet cPOC.
· Work collaboratively with multiple stakeholders, propose solutions for potential problems within and across projects and develop appropriate contingency plans.
· Represent statistical programming to cross functional team members. Present statistical programming concepts, risk assessments and impact, and logical arguments to cross colleagues in OED.
May be responsible for managing statistical programming staff.
· MS in Statistics, Computer Science, or a related field with 8+ years of relevant experience. Or BS in Statistics, Computer Science, or a related field with 8+ years of relevant experience.
· In-depth understanding of CDISC Standards and SAS programming concepts and techniques related to drug development.
· Degree of technical competence and communication ability, both oral and written.
· Competent in SAS programming and Macro development.
· Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA, EMEA, and PDMA preferred.
· Understanding of ICH guidelines and relevant regulatory requirements.
· NDA/BLA or other regulatory filing experience, including ISS or ISE experience preferred.
CRO oversight and vendor management experience preferred.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.