Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
Must be able to come onsite 3 days per week
Purpose:
The Associate Director, Statistical Programming leads the whole stat programming team within CDOR (Clinical Data Operation and Reporting) in OED (Oncology Early Development) clinical development organization.The stat programming team performs statistical programming and analysis oversight for OED all clinical projects conducted by CROs. The associate Director leads the recruitment and training of new staff onboarding activities, manage the overall resource allocation and monitoring on regular basis, provide technical guidance for team members, performs ongoing and annual performance management and staff career development, initiate and lead stat programming related process improvement collaborating with CRO partners, create a collaborative team work environment for both internal staff as well as with CRO partners, build strong relationship with internal and external stakeholders management. This person may also need to support clinical projects if needed, therefore strong hands on stat programming skills for both analysis datasets and TLFs in oncology therapeutics are fundamental to the success of this role.
Responsibilities:
SAS Programming: Demonstrated extensive understanding of SAS programming concepts and techniques appropriate to the pharmaceutical industry. Demonstrated proficiency in applying SAS programming knowledge to solve problems related to non-routine situations. Standards: Oversees effort to determine and implement global company standards related to output design and programming conventions. Responsible for monitoring regulatory guidance and industry best practices.
Case report forms and database definitions: Provides strategic guidance on the development of CRFs and database designs. Provides in-depth critical review of global standards related to CRF designs and database designs. Derivation Programming, Submission Data Sets and Programs: Demonstrated proficiency in interpreting statistical analysis plans and developing analysis data set specifications. Oversees effort to determine and implement global company standards related to derive data sets and subm
Works collaboratively with multiple stakeholders to manage priorities and resources across therapeutic areas. Demonstrates an understanding of drug development principles. Anticipates potential problems within and across projects and develops appropriate contingency plans. Creates escalation plans to ensure resolution of all issues at the therapeutic and project levels. Participates in and is viewed as a key contributor to cross functional initiatives.
Effectively and persuasively presents statistical programming concepts, assessment of risks and impacts and logical arguments to other statistical programmers, statisticians, scientists and non-scientists. Effectively presents information through planning and execution of meetings and presentations.
Training and Mentoring: Provides appropriate background and motivation to staff. Arranges appropriate training opportunities for staff to facilitate their timely career development. Ensures that self and staff are compliant with training requirements. Effectively mentors statistical programming staff with regard to functional operations.
Manages statistical programming staff by appropriate assignment of responsibilities, defining scope and reviewing activities/progress so that projects are delivered on time with suitable quality. Allocates resources to projects such that the correct balance of expertise and experience is maintained for all projects. Works collaboratively with the statistical programming management team to assess project resource requirements versus current staff
Establishes high expectations and goals to ensure organizational success and leads staff to meet or exceed those goals. Creates an organization that executes efficiently and is committed to meeting goals. Encourages a culture of open, honest communication where all are encouraged to express their views. Provide all performance management activities for 4-10 statistical programmers
.
Qualifications
MS in Statistics, Computer Science or a related field with 10+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 12+ years of relevant experience.
High degree of technical competence and communication ability, both oral and written. Highly competent in SAS programming and Macro development. Pharmaceutical experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA. NDA/BLA or other regulatory filing experience, including ISS or ISE experience. Thorough understanding of ICH Guidelines and relevant regulatory requirements. A minimum of 2 yrs management experience required, 2-5 years preferred.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:
- The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
- This job is eligible to participate in our short-term incentiveprograms.
- This job is eligible to participate in our long-term incentiveprograms
Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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