Sr. Manager, Statistical Programming
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.
What Your New Manager Wants You To Know
The role of the Senior Manager is to manage statistical programming activities to ensure they are appropriately planned and executed for all assigned Phase I- IV clinical studies sponsored by Abbvie and its partners. This senior level position serves as a compound lead, independently performs statistical programming for clinical studies and integrated summaries, and prepares responses to requests from regulatory authorities. The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Abbvie policies and procedures.
YOU ARE more than just a title, YOU ARE...
A strategic thinker : align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.
First class team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.
- Provide programming and documentation support for multiple studies with good quality
- Review statistical analysis plans for all assigned studies and integrated summaries and provide comments to study biostatistician
- Create ADaM data set specifications for all assigned studies and integrated summaries
- Ensure study analysis is consistent with standard templates and specifications
- Lead the Statistical Programming submission support, including managing timelines, tasks, and resources
- Follow timelines for assigned study tasks
- Contribute to development of new standard templates
- Review and author standard operating procedures and supporting documents related to Statistical Programming processes
- Participate in a Statistical Programming process improvement initiative(s)
- Participate in a Statistical Science and Programming process improvement initiative(s)
- Contribute to cross - functional process improvement initiative(s)
- Manage timelines and ensure good communication with CROs/FSPs and internal programmers
- Conduct high level review of deliverables provided by CRO/FSP to ensure good quality and accuracy
- Oversee programming tasks for multiple studies
- Ensure analyses for multiple studies are consistent with standard templates and specifications
- Oversee programming tasks for >=2 programs
- Ensure analyses for all studies within a program are consistent with program defined standard templates and specifications
- Mentor/oversee more junior level staff
- Lead working group assigned to develop new standard templates as needed
- Lead SP process improvement initiative
- Participate in the evaluation and adaptation of new computing technology and programming practices related to statistical programming and systems development.
- MS in statistics or equivalent with at least 6+ years' experience in Statistical Programming supporting drug development, submission, and approval in the pharmaceutical/biotech/device industry or CRO
- Bachelor's degree with at least 8+ years' experience in Statistical Programming supporting drug development, submission, and approval in the pharmaceutical/biotech/device industry or CRO
In this role, we're looking for a leader who will :
Act as an Owner and a leader, Be Excellence Focused, Act as an Influencer
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.