Minimum Requirements | Role Responsibilities
· Expertise in extracting, manipulating, summarizing, analyzing, and presenting data using SAS procedures· Expertise in SAS/MACRO, SQL, and SAS/BASE procedures· Expertise/experience in use of SAS/GRAPH and Statistical procedures· Highly experienced working in Clinical data and medical dictionaries· Knowledge of relational database principles· Able to program in Linuxenvironment· Strong understanding of clinical trials – how programming deliverables fit in to the process, what types of data are collected· Data structure understanding (BDS – Basic Data Structure, CDISC SDTM and ADaM)· Able to draft programming requirements from statisticalanalysis plan· Strong experience with studyreporting· Previous experience using CDARS –Preferable· Preferred Masters (US) BSc (Europe) in | · Create submission-ready standard data presentations and data sets using standard coding· Create submission-ready non-standard data presentations and data sets using non- standard coding· Conduct programming activities associated with interim analysis, QC, eSub, etc. as required· Develop and run production or QC programs· Review tables/listings, edit checks output and SAS programs, specifications, other programming documentation, etc to ensure quality ofdeliverables· Write complete, concise, and unambiguous technical documents (e.g., Lists of Tables, Mock tables, code specifications and program documentation, QC plans, QC implementation).· Understand and plan work to delivery timelines including allowing time for internal Pfizer QC, asappropriate· Work with supervisor and Pfizer contact to balance conflicting priorities· Understand timelines for andmilestones
statistics or a related science· Knowledge of routine statisticalmethodology and its application· Understands and applies the value of programming and process standards in the achievement of long-termobjectives· Understands the use of established standards, SOPs and best practices.· Independent, follows through on assignments, able to work with minimal oversight· Proven ability to propose and implement solutions to technical coding issues· Able to ask the right and critical questions; identify issues, explore options and make suggestions· Recognizes when negotiating skills are needed and seeksassistance· Ability to provide technical mentorship to junior programmers· May have experience of leading programming teams and projects and capable of managing at a compound or submission level· Excellent and proactive communication skills (especially around programmer assignment and output delivery time).· Excellent written and verbal communication skills and interpersonal skills and discussing analytical methods· Ability to make tactical decisions on defined aspects of statistical programming and processes/standards used in its development | affecting work and alert supervisor and Pfizer contact to potential slippage· Provide updates and alerts to points of contact (in time for remediation) including:o Potential slipped delivery timeo Planned change toresourceo Quality issues orconcerns· Ensure training done before embarking on a task· Alert supervisor and Pfizer contact where skills or knowledge are not adequate for the task set – seek help· Follow escalation process and neither suppress nor over-escalate issues· Ensure updates to action / progress logs are completed in timelyfashion· Produce accurate project status and progress reports as necessary· Coordinate work on multiple projects according topriorities· Suggest improvements to standard work processes e.g., suggests new software applications to improve work efficiency/quality· Supports and leads efforts to implement new concepts, process improvement, and technological advances for delivering outputs· Use and promote the use of established standards, SOPs and best practices.· Present technical information to a non- technical audience· May be a Primary contact to Pfizer for a group of programmers all working on same project· Project management of a study, a portfolio of studies, or submissions, managing overall day-to-dayoperations· Quality overview of programming activities
Compensation: $80,000.00 - $130,000.00 per year
TK-CHAIN® is a Lifesciences Consulting and Staffing Solutions company, helping pharmaceutical, biotechnology, medical devices, and clinical research companies streamline processes in drug and vaccine discovery, through proprietary systems, processes, and methodologies, TK-CHAIN® can map key customer problems, and offer customized solutions. Since the company began operations, it has enforced a performance-driven, and results-oriented culture, making it a reliable, and widely acclaimed partner for high-profile R & D client projects.
For more than 35 years of combined experience, companies have turned to TK-CHAIN for the highest caliber of talent solutions, knowing that we have an extensive network of global seasoned consultants that can be trusted to get the job done.
That’s because we know our consultants and the industries we serve. We constantly build new relationships through personal referrals and references to ensure the best and brightest minds are part of our TK-CHAIN talent network.
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