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 Ability to identify solutions, resolve validation differences for SAS\xc2\xae program outputs, and knowledge on when to bring in leadership for support 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) Ability to read and understand SAS\xc2\xae programming code developed by other programmers, including making changes to the existing code Provide technical solutions to a wider range of problems with higher level of complexity. Independently determine and develop approach to solutions Create and/or review SDTM and/or mapped data specifications of simple complexity Review analysis dataset/ADaM specifications Employ standardized programs where applicable Ability to provide quality output and deliverables in adherence with challenging timelines Responsible for accuracy and reliability of results Achieve high billability and margins on all projects (targets TBD) Consider strategies that will allow efficiencies to be recognized in subsequent tasks (e.g., multiple studies in an ISE or ISS) Ensure the efficiency, quality, and integrity of data reporting through document, data, and output reviews Understand the overall design of a clinical study and its statistical and clinical rationale

Management,

Learning &

Development Support projects and execute Statistical Programming activities according to timelines and milestones in a timely manner without sacrificing quality Efficiently manage multiple tasks and project 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 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 Provide input into CRF design to ensure it conforms with study protocol, analysis needs, and format requirements such as CDISC standards 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 Assist project leads with identification of out of scope work Identify project risks and provide solutions prior to impact on deliverables Lead Statistical programming activities of a set of studies for a single sponsor

Benefits

Requires a Bachelors degree, Masters degree preferred in a scientific discipline SAS Advance Programming Certificate preferred Minimum 5-8 years of relevant work experience Minimum 5-8 years of experience in drug development and/or clinical research. Thorough knowledge of computer systems, applications and operating systems Strong analytical skills Ability to simplify complex issues into understandable concepts Provide mentoring to junior staff

Skills Strong written and verbal communication skills including good command of English language Proficiency with various computer applications such as Word, Excel, and PowerPoint required Requires advanced knowledge of SAS/Base, especially macros, arrays, formats and ODS Good knowledge of SAS/STAT and SAS/GRAPH is also required Requires familiarity with basic statistical principles to interact with biostatisticians Requires good written skills and ability to interpret and implement table manuals and statistical analysis plans Requires familiarity with drug development principles related to the production of databases and summary tables, such as CDISC standards and ICH-GCP guidelines Requires ability to write validation plans

Allucent