Senior Manager, Statistical Programming
EnantaWatertown, MA, USjob_description.job_card.1_day_ago
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job_description.job_card.job_descriptionMaster’s Degree in Statistics, Biostatistics, Mathematics, Computer Science, Biotechnology, Pharmaceutical Science and 6 years of experience as a SAS Programmer, Statistical Programmer, Senior Statistical Programmer, or Statistical Programming Lead, at Biotech, Pharma, Clinical Research Organizations (CRO), or other relevant organizations. Alternatively, a Bachelor’s Degree in Statistics, Biostatistics, Mathematics, Computer Science, Biotechnology, Pharmaceutical Science and 8 years of experience as a SAS Programmer, Statistical Programmer, Senior Statistical Programmer, or Statistical Programming Lead, at Biotech, Pharma, Clinical Research Organizations (CRO), or other relevant organizations. Proficiency in CDISC standards for SDTM, ADaM, and FDA electronic data submission requirements as demonstrated by leading statistical activities throughout clinical development for multiple programs. Proven ability to analyze complex data and clearly present findings related to clinical trial results, Exceptional verbal and written communication skills, enabling cross-functional collaboration, with a demonstrated ability to clearly articulate complex statistical information cross-functionally. Proven success in the pharmaceutical or biotechnology industry, as demonstrated by providing statistical programming support including developing programming specifications showing an understanding of regulatory submissions requirements. Experience in managing and partnering with or overseeing CROs or Programming Vendors related to data flow and analysis supporting clinical trials.
Primary Responsibilities :
- Be an integral part of the Biometrics team, collaborating across interdisciplinary teams such as Biostatistics, Data Management, Clinical Operations, Regulatory, and Pharmacovigilance, as well as CROs to advance our innovative clinical programs.
- Lead Statistical Programming Initiatives including responsibility for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced programming deliverables.
- Analyze Data including review CRF design and help data collection and cleaning, developing / reviewing SAP, TFL shells and SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues.
- Produce and / or validate tables, listings, figures, and analysis datasets using statistical software in response to regulatory requests, publication requests, and ad-hoc analyses; write specifications to describe programming needs.
- Perform integrated analysis based on pooled data to identify safety signals, relationships and trends or any factors that could help with clinical development.
- Create graphs, charts, or other visualizations to convey the results of data analysis using specialized software (SAS, R).
- Manage Projects to include owning the success of project budget, timelines and schedules of specific phases of projects and collaborating with internal personnel and outside customer representatives.
- Seek out and bring novel data-driven solutions to tackle scientific and operational challenges, including identifying problems and developing global tools that increase the efficiency and capacity of the Statistical Programming group.
Qualifications :
Salary Range : $161,803 / year - $178,000 / year.
Work Location : Watertown, MA
40 hours / wk.
LI-DNI
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Senior Manager Programming • Watertown, MA, US