Biotech/Pharmaceutical

Sr. Statistical Programmer – Remote

Contract

Penfield Search Partners

Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com

Job Description: The Associate Director will provide leadership for statistical programming aspects of phase 1 to phase 4 clinical studies by ensuring timely completion and high quality of all required deliverables.

Responsibilities:

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  • Lead statistical programming projects through life cycle.
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  • Develop specifications for CDISC compliant SDTM domains and ADaM datasets.
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  • Create annotated CRFs for SDTM.
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  • Develop SAS programs to convert clinical studies data into SDTM datasets, and ADaM datasets per specifications.
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  • Write SAS programs to generate tables, listings, and figures (TLFs) per client requirements as outlined in study SAP.
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  • Produce final define packages (containing define.xml, reviewer’s guide, etc.) for SDTM and ADaM.
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  • Validate other team members’ work via independent programming in SAS.
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  • Participate in development of standards and create efficient processes. 
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  • Collaborate with project team to ensure timely delivery and quality of all statistical programming related deliverables
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  • Mentor junior statistical programmers.
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  • May be responsible for managing other statistical programmers.
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  • May provide operational support, including the ongoing development and improvement of business practices and processes.
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  • Support the project team in all aspects of statistical programming activities.
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Qualifications:

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  • Undergraduate or graduate degree in Statistics, Mathematics, Bio-informatics, Physical Sciences, or related fields.
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  • Minimum of 8 years (10 years for an undergraduate degree) of experience in statistical programming, analysis, and reporting within the context of drug development projects.
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  • Demonstrated experience of programming in SAS 9.x.
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  • Thorough knowledge of CDISC standards.
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  • Extensive experience in creating SDTM, ADaM, Tables, Listings and Figures, as well as define.xml, and Reviewer’s guides.
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  • Hands-on experience in annotating CRF pages per FDA guidelines.
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  • Demonstrated knowledge of clinical drug development.
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  • Proficiency in conducting advanced statistical analyses.
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  • Strong track record of working in various therapeutic areas.
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  • Knowledge of R (in addition to SAS) is a plus, but not required.
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  • Familiarity with project planning tools such as MS Project or similar and concepts such as task dependencies.
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  • Alternate combination of education, experience and training may be considered.
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  • Skills & Abilities:
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  • Ability to prioritize and manage multiple projects in a fast-paced deadline driven environment while delivering high quality results.
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  • A quick learner able to rapidly grasp and master new/changing business needs.
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  • Excellent communication skills in English, and ability to adapt communication styles to varied internal and external partners.
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  • Strong problem-solving skills and attention to detail.
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  • Ability to work independently within a team environment.
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  • Ability to work collaboratively with other team members and across business units.
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Tagged as: Sr Statistical Programmer - Remote