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Manager, Statistics

3 months ago

Florham Park, New Jersey, United States AbbVie Full time

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

Purpose:

The Manager, Statistics provides statistical expertise to support the research and development organization. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Manager works independently in partnership with experts in multiple disciplines to advance medicines to our patients.

Responsibilities:

Provide expertise to design, analysis and reporting of clinical trials or other scientific research studies. Independently develop protocols and/or statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation) with details for programming implementation. Implement sound statistical methodology in scientific investigations.Identify scientifically appropriate data collection instruments. Identify and report data issues or violations of study assumptions. Provide programming specifications for derived variables and analysis datasets. Partner with Data Science in preparing for database lock.Independently perform statistical analyses as per the analysis plan. Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to agreed-upon timelines. Identify and anticipate issues arising in the study design, conduct and propose scientifically sound approaches. Evaluate appropriateness of available software for planned analyses and assess needs for potential development of novel statistical methodology.Develop strategy for data presentation and inference. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures. Ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with statistical analyses provided.Work collaboratively with multifunction teams. Clearly explain statistical concepts to non-statisticians. Provide responses to questions, and pursue analyses suggested by data. Support communications between assigned product team(s) and functional management. Build/drive cross-functional relationships and collaboration.(SSG) Collaborate with cross functional team for benefit-risk planning and assessment. Contribute to cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests.(SSG) Collaborate/lead within the Safety Statistics Group to implement strategic initiatives that address processes related to interpreting, monitoring, assessing, and reporting safety data to characterize the safety profile of AbbVie products, improve efficiencies, and provide consistency across therapeutic areas.(GMA Stat) In collaboration with GMA, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility assessment to identify fit-for-purpose data sources to address research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions. Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications
*This position will be required to sit on-site 3 days / week*

Qualifications:

MS (with 6+ years of experience) or PhD (with 2+ years of experience) in Statistics, Biostatistics, or a highly related field.High degree of technical competence and effective communication skills, both oral and writtenAble to perform statistical computations and simulationsAble to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from othersAble to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quoPharmaceutical or related industry knowledge desired, including experience and understanding of drug development and life-cycle management in the regulated environment.(GMA Stat) Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming. Knowledge of methodologies for confounding control and bias minimization in observational studies 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 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.