Statistical Analytics Contractor (SAS Programming)
Job Location: New York, NY
Pharmaceutical industry; NY area, 6 months renewable;
The Statistical Programmer supporting Medical Analytics within Medical Affairs will be responsible for the statistical programming aspects and deliverables for products/projects in regards to Medical Affairs activities with guidance and/or direct supervision from senior Medical Analytics colleagues. Together with Medical Analytics (Biostatistics), Medical Affairs and HEOR colleagues, he/she will plan and execute statistical analysis, provide input into and align with the publications plan, and support Medical Affairs/HEOR analysis needs. He/she will need strong communication skills to understand the research question, implement complex statistical analyses, and explain analysis implementation (in particular, details regarding the specific analysis implementation, definitions and/or output generation).
Serve as the statistical programmer for products/projects with guidance and/or direct supervision from senior Medical Analytics colleagues.
Plan and Execute Statistical Analysis:
Author parts of and/or provide significant input into the Statistical Analysis Plan (SAP) to comprehensively and unambiguously define the statistical analysis specifications, data derivations, and display shells to be generated in collaboration with key stakeholders. Perform statistical analyses using SAS to generate tables, listings, and figures for use in publications/presentations and for internal purposes. Ensures quality of deliverables through appropriate testing/validation and active review for completeness and accuracy (including developing and implementing a well-documented validation plan). Understand ICH, GCP and health authority guidelines with regard to reporting and associated regulations and standards (including CDISC standards).
Statistical Programming Experience:
Experience in statistical programming methods to support Medical Affairs including analysis using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials). Expert proficiency in SAS/STAT modules that support linear models, categorical data, and time-to-event data. Familiarity with SAS high-resolution graphics to supplement aforementioned statistical models. Ability to make use of standard macros or author specialized limited-use macros. Experience in statistical programming methods to support Health Economics and Outcomes Research including analysis related to patient reported outcomes (including development/validation) and HTA
eimbursement/value dossiers, and real world studies (for example, registries). Strong communication skills to understand/document the SAP requirements and explain/discuss implementation details of complex statistical analyses to both technical and non-technical audiences
Experience in executing statistical analysis by authoring parts of and/or providing significant input in the SAP, implementing the SAP using SAS, ensuring quality via validation, and explaining implementation details to technical and non-technical audiences.
Experience in statistical programming methods as it relates to the following areas:
Medical Affairs analyses using the clinical database for scientific meetings, publications, and internal decision-making (generally based on previously conducted randomized clinical trials). Health Economics and Outcomes Research analyses including analysis related to patient reported outcomes (including development/validation), HTA
eimbursement/value dossiers, and real world studies. MS/PhD in statistics/ mathematics/ engineering/computer science/life sciences or related discipline with at least 3 years of experience in statistical programming using SAS in the biotechnology, pharmaceutical or health related industries.
MS/PhD in statistics/mathematics/engineering/computer science/life sciences or related discipline (see Educational Requirements/Experience for more information). Expert knowledge of statistical programming methods using SAS to solve statistical problems.
Please contact Darren Gutowski at email@example.com
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