Job Description

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. The Senior Statistical Programmer I (SrSP I) coordinates the programming of clinical data analysis activities of CATO SMS Statistics. This position controls and monitors the activities of a Statistics project team, while programming datasets and outputs using SAS and will interact with other members of the CATO SMS project team. The SrSP I is a member of the Statistics staff. Requirements Responsibilities Statistics Business planning, Management and Strategy \xc2\xb7 Ability to identify solutions, resolve validation differences for SAS\xc2\xae program outputs, and knowledge on when to bring in leadership for support \xc2\xb7 Create and execute SAS\xc2\xae programs according to project specifications for outputs of any complexity, including, but not limited to, mapped and analysis datasets, tables, listings and figures (TFLs) \xc2\xb7 Ability to read and understand SAS\xc2\xae programming code developed by other programmers, including making changes to the existing code \xc2\xb7 Provide technical solutions to a wider range of problems with higher level of complexity. Independently determine and develop approach to solutions \xc2\xb7 Create and/or review SDTM and/or mapped data specifications of simple complexity \xc2\xb7 Review analysis dataset/ADaM specifications \xc2\xb7 Employ standardized programs where applicable \xc2\xb7 Ability to provide quality output and deliverables in adherence with challenging timelines \xc2\xb7 Responsible for accuracy and reliability of results \xc2\xb7 Achieve high billability and margins on all projects (targets TBD) \xc2\xb7 Consider strategies that will allow efficiencies to be recognized in subsequent tasks (e.g., multiple studies in an ISE or ISS) \xc2\xb7 Ensure the efficiency, quality, and integrity of data reporting through document, data, and output reviews \xc2\xb7 Understand the overall design of a clinical study and its statistical and clinical rationale Management, Learning & Development \xc2\xb7 Support projects and execute Statistical Programming activities according to timelines and milestones in a timely manner without sacrificing quality \xc2\xb7 Efficiently manage multiple tasks and project \xc2\xb7 Has good understanding of data collection and database concepts including data flows in clinical trials and biopharmaceutical industry data standards, such as CDISC SDTM and ADaM data models Quality Management \xc2\xb7 Review and/or provide guidance on data management plans, project database structures, Case Report Forms (CRF) (including annotations), edit checks, data mapping conventions, and other relevant and associated Data Management and vendor documents \xc2\xb7 Provide input into CRF design to ensure it conforms with study protocol, analysis needs, and format requirements such as CDISC standards \xc2\xb7 Prioritize and delegate tasks based on the importance of the deliverable and display awareness of overall timelines, in order to efficiently produce high quality deliverables Account Management, Sales & Acquisition \xc2\xb7 Assist project leads with identification of out of scope work \xc2\xb7 Identify project risks and provide solutions prior to impact on deliverables \xc2\xb7 Lead Statistical programming activities of a set of studies for a single sponsor Benefits Requires a Bachelor\xe2\x80\x99s degree, Master\xe2\x80\x99s degree preferred in a scientific discipline \xc2\xb7 SAS Advance Programming Certificate preferred \xc2\xb7 Minimum 5-8 years of relevant work experience \xc2\xb7 Minimum 5-8 years of experience in drug development and/or clinical research. \xc2\xb7 Thorough knowledge of computer systems, applications and operating systems \xc2\xb7 Strong analytical skills \xc2\xb7 Ability to simplify complex issues into understandable concepts \xc2\xb7 Provide mentoring to junior staff Skills \xc2\xb7 Strong written and verbal communication skills including good command of English language \xc2\xb7 Proficiency with various computer applications such as Word, Excel, and PowerPoint required \xc2\xb7 Requires advanced knowledge of SAS/Base, especially macros, arrays, formats and ODS \xc2\xb7 Good knowledge of SAS/STAT and SAS/GRAPH is also required \xc2\xb7 Requires familiarity with basic statistical principles to interact with biostatisticians \xc2\xb7 Requires good written skills and ability to interpret and implement table manuals and statistical analysis plans \xc2\xb7 Requires familiarity with drug development principles related to the production of databases and summary tables, such as CDISC standards and ICH-GCP guidelines \xc2\xb7 Requires ability to write validation plans