Senior Manager, Statistical Programming - Oncology Early Development
PowerToFly
Job Description The Senior Manager, Statistical Programming performs statistical programming and analysis oversight for Oncology Early Development (OED) clinical projects conducted by CROs. This individual is responsible for overseeing several compounds/indications on all statistical programming related tasks delivered by CROs. The goal is to ensure data integrity and high quality of all the analysis for oncology first-in-human clinical trials up through clinical proof of concept. This individual also performs hands‑on programming to validate analysis datasets and TLFs delivered by CROs and supports in‑house studies for the full set of analysis tasks. The individual may also need to manage other regular or contract statistical programmers. Responsibilities Leads the statistical programming activities for one or more compounds/indications or a therapeutic area. Manages a team of statistical programmers and the resource planning for their assigned projects. Ensures timely deliverables, that all quality processes are followed and consistency within the projects. Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards. Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures. Ensures consistency of ADaM data sets for individual studies and integrated data. Creates documentation for regulatory filings including reviewers guides and data definition documents. Leads the development of standard SAS Macros and the development of standard operating procedures. Manages, mentors and creates career development plans for assigned staff. Participates in the recruitment and selection of new staff. Qualifications MS in Statistics, Computer Science or a related field with 9+ years of relevant experience; or BS in Statistics, Computer Science or a related field with 11+ years of relevant experience. Minimum of 2 years experience leading a team of statistical programmers. In‑depth understanding of SAS programming concepts and techniques related to drug development. In‑depth understanding of CDISC Standards. In‑depth understanding of the drug development process, including experience with regulatory filings. Ability to communicate clearly both oral and written. Ability to effectively represent the Statistical Programming Organization in cross‑functional teams. Ability to accurately estimate effort required for project related programming activities. Additional Information 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 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 employer 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 an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. #J-18808-Ljbffr PowerToFly
$124.5k - $236.5k
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- PowerToFly is looking for a Senior Manager, Statistical Programming to oversee statistical programming for Oncology Early Development clinical projects. This role involves leading a team and ensuring the integrity of analyses for first-in-human clinical trials. The ideal...Senior
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- ...areas including immunology, oncology and neuroscience - and... ...Job Description The Senior Manager, Statistics provides statistical leadership... ...support the research and development organization for assigned... ...other scientific research programs. Independently develop protocols...SeniorFull timeWork experience placementLocal area
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$160.5k - $305k
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- AbbVie seeks a senior Statistics professional to provide statistical leadership for drug development and lifecycle management. The role includes protocol development, method selection... ...communication skills, and the ability to lead a programming group across global teams in a...Senior
- A leading biopharmaceutical company is seeking a Senior Manager, Statistics to provide statistical leadership for research and development projects. This hybrid role requires 8+ years of experience with an MS or 4+ years with a PhD in a relevant field. Responsibilities...Senior
- ...areas including immunology, oncology and neuroscience - and products... ...is integral to a Quality Management System in GCP for R&D. Compliance... ...(CLCM), within Clinical Development Operations, sustains an... ...infrastructure, change management programs, and forums in alignment...SeniorFull timeLocal area
- AbbVie in North Chicago, IL is seeking a Manager of Statistical Programming to lead a team of statistical programmers in neuroscience drug development, ensuring CDISC ADaM data sets, Tables, Listings and Figures are produced accurately and on time. The role interfaces...
- ...therapeutic areas immunology, oncology, neuroscience, and eye care... ...Biologics Drug Product Development (Bio DPD), a part of Development... ...candidate for the position of Senior Scientist II, located in... ...plans to stakeholders and line management. Represent Bio DPD in the...SeniorTemporary work
$109.5k
...including immunology, oncology and neuroscience -... ...to transform clinical development and R&D Collaborate... ...addition to standard statistical methods, develops prototypes... ...environment and in managing multiple priorities... ...long-term incentive programs. ? Note: No amount...SeniorLocal area- ...therapeutic areas including immunology, oncology and neuroscience - and products... ...and YouTube. Job Description The Senior Research Statistician in Statistical Innovation is responsible for... ...modeling and simulation in Clinical Development. Responsibilities: Actively supports...SeniorTemporary work
- ...including immunology, oncology and neuroscience -... ...Purpose: The Sr Manager Process Excellence Lead... ...optimizing Oncology Early Development business processes (... ..., data management, statistical programming and medical... ...function heads and senior leadership for alignment...SeniorFull timeLocal area
- ...including immunology, oncology and neuroscience... ...to support development plans and strategies... .../PD modeling and statistical data analysis.... ...Pharmacometrics management. Responsibilities... ...Clinical Pharmacology senior management in the... ...-term incentive programs. Note: No amount...SeniorLocal area
- ...including immunology, oncology and neuroscience -... ...Description The Senior Director will be... ...innovative and unique early stage pipeline... ...with formulation development support for conventional... ...analytical and program strategies into... ...will effectively manage Discovery Research...Senior
- ...therapeutic areas – immunology, oncology, neuroscience, and eye... ...Drug Product Development (Bio DPD), a part of... ...candidate for the position of Senior Scientist II, located... ...stakeholders and line management. Represent Bio DPD... ...short-term incentive programs. Note: No amount...SeniorTemporary workLocal area
- ...areas – immunology, oncology, neuroscience, and eye... ...headquarters. Physician’s Development Program Overview AbbVie’s... ...Development (both early and late stage.) In... ...safety, and risk management plans. Responsible for... ..., discovery, statistics, regulatory, etc.) as...Rotational programFull timeTemporary workLocal area
- ...therapeutic areas including immunology, oncology and neuroscience - and products and... ...Engineering Organization, a part of AbbVie’s Development Sciences organization, is responsible... ...drug product development scientists, program managers, and regulatory affairs specialists....SeniorTemporary workWork experience placementLocal area
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- ...including immunology, oncology and neuroscience -... ...Research & Development (Biologics Analytical... ...The biologics early analytical development... ...well as the overall program. Work in... ...Qualification for Senior Scientist I: Ph.D.... ...time organization/management skills coupled with...SeniorTemporary workLocal area
- ...areas including immunology, oncology and neuroscience - and products... ..., a part of AbbVies Development Sciences organization in Synthetic... ...all phases of development. Early in development, engineers focus... ...development scientists, program managers, and regulatory affairs specialists...Senior
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