- Provide strategic input to and oversight of the development of Product Safety Statistical Analysis Plans (PSSAPs) and Integrated Summary of Safety Statistical Analysis Plans (ISS SAPs).
- Ensure consistency across documents (eg, PSSAP, study SAPs, ISS SAP).
- Provide strategic input on safety related submissions to regulatory agencies and responses to requests from regulatory agencies.
- Attend regulatory meetings.
- Oversight of the development of safety data integration specifications in accordance with analysis plan.
- Lead and provide oversight of contributions by Safety Statistics to benefit-risk planning and assessment, including ensuring delivery and interpretation of benefit-risk data displays/analyses.
- Oversight of the development, delivery and interpretation of safety outputs, including graphics.
- Oversight of cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests.
- Oversight to ensure the delivery of high-quality outputs according to agreed-upon timelines.
- Ensure appropriate interpretation of safety deliverables in collaboration with other functions.
- Identify potential areas to improve processes or statistical methodologies, initiate steps to evaluate possible improvements and develop a plan to implement changes based on this evaluation.
- Lead within-SSG initiatives and represent SSG on cross-functional efforts to implement strategic initiatives that address processes related to monitoring, assessing, interpreting, and reporting safety data.
- Potentially represent SSG/DSS on external initiatives to advance the safety discipline (e.g., ASA, PHUSE, DIA, etc.), depending on individual interests.
- Responsible for project and resource management within SSG for therapeutic area(s) of responsibility.
- Mentor team members and provide appropriate development opportunities.
Qualifications - MS (with at least 14 years of experience) or PhD (with at least 10 years of experience) in Statistics, Biostatistics, or a highly related field, with at least 7 years (MS) or 5 years (PhD) of experience in pharmaceutical development.
- Minimum of 2 years of management experience required for people managers.
- Excellent English communication skills, both oral and written
- Advanced knowledge of statistical methodology including experimental design, descriptive statistics, inferential statistics, and statistical programming.
- Must have demonstrated exemplary statistical experience in managing and completing multiple projects or equivalent experience.
- In-depth knowledge and understanding in application of standard business procedures (regulatory guidance, global regulations, ethical issues associated with scientific research trials, SOPs, etc.).
- Experience interacting with regulatory agencies.
- Experience in leading NDA, BLA, and or CTD submission preferred.
- Oversight of multiple safety-related projects (e.g., ISS, PSSAP, benefit-risk assessment, signal detection). AbbVie is an equal opportunity employer including disability/vets. It is AbbVies 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a persons relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
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 the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance 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 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 committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.
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Director, Statistics - Madison, United States - AbbVie
Description
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 Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
The Safety Statistics Group (SSG) at AbbVie is an important strategic part of Data and Statistical Sciences (DSS). Safety Statisticians are part of collaborative, cross functional teams including members from Pharmacovigilance and Patient Safety and Epidemiology (e.g., product safety team physicians, epidemiologists, safety analysts), Statistical Programming, Clinical Statistics, Regulatory Affairs, and Medical Writing. Safety Statisticians work on products in the AbbVie portfolio ranging from early to later stages of development and life cycle management, with a focus on evaluation, interpretation, and reporting of aggregate/integrated safety data, including benefit risk planning and assessment.
AbbVie is seeking an experienced statistician to serve in a leadership role in our Safety Statistics team. The Director, Safety Statistics will have oversight of statisticians in one or more therapeutic areas.
Key Responsibilities:
