Kellton Tech

Kellton Tech is a full-service software development company, offering end-to-end IT solutions, strategic technology consulting and product development services in Web, SMAC (Social, Mobile, Analytics, Cloud), ERP-BPM, and IoT space Our methodology of inventing infinite possibilities with technology helps us develop best in-class and cost effective solutions for our clients. Currently Kellton Tech is looking for talented resources for one of our listed client. Below are the position details: Title: Power BI consultant Tenure: 12 Months Location: MN REQUIRED SKILLS: Job Description Power BI developers with strong SQL skills Need someone with great communication skills Apply: Interested candidates can apply with their detailed word formatted resume along with their contact information\availability to Phone (off)-Ext 131. Thanks for all your time! - provided by Dice

Hi, We have an exciting opportunity for the role of "Senior Biostatistician" with our client. Please check the job description as below and let me know your interest. In case you are not looking for any change, I'd appreciate if you could refer any friends/ colleagues who might be interested in it. Title: Senior Biostatistician Duration: 12+ Months Location: Jersey city, NJ Description: Work with the clinical study team on study design, development and/or review of clinical study protocols. Contribute to clinical trial design, protocol concept sheet and protocol development Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc. Develop and/or review statistical documents and deliverables for clinical trials including Statistical Analysis Plan (SAP) for individual studies and integrated summaries of drug efficacy and safety, Table, Listing and Graph (TLG) shells, statistical validation plan, Data Set Specification (Rule Book), Data Monitoring Committee Charter and interim analysis plan, Clinical Study Report (CSR) and others Work with clinical data managers on design/review of case report form, data transfer specification, edit check specification, and participation in user acceptance testing (UAT); generate/review data tables/listings and coordinate data review meetings during the course of the study to ensure data quality. Oversee programming activities, perform quality assurance checks on internally or externally produced SAS tables, listings, and figures, and ensure the quality of deliverables. Perform post-hoc statistical analyses as needed. May work on submission teams as a statistician and/or a programmer. Generate and QC outputs for publications; review publication (abstract/man====ripts) to ensure accuracy, quality and soundness of statistical methodologies Will serve as lead Statistician on complex trials and across multiple studies. Project work including participating in the development of Clinical Development Plans (CDPs) and the protocol development process, developing and implementing Statistical Analysis Plans (SAPs), supervising CROs and interfacing with co-promoters, attending IPT meetings, consulting with clinical or regulatory affairs groups on strategic issues related to compound development, study designs, analysis, resource needs and future plans. Managing non-project work including infrastructure development initiatives and involvement in committees working to develop SOPs and SWPs to improve quality, efficiency and timeliness of work processes. Facilitate teams to identify issues related to biostatistics and propose solutions; manage day-to-day biostatistics operations and help to develop resource allocation to execute biostatistics initiatives as needed. QUALIFICATIONS: Must have a MS in Biostatistics/Statistics with at least 5 years of experience or a PhD in Biostatistics/ Statistics with at least 4 years of experience in the pharmaceutical, CRO or biotech industry. Strong SAS programming skills. Oncology experience is required. Ability to effectively work on multiple projects Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality. Applies good judgment and leads problem solving within the team Familiar with oncology clinical trial Phase I-III design and survival analysis, submission experience will be plus. - provided by Dice

Hi, We have an exciting opportunity for the role of "Associate Director, Biostatistics" with our client. Please check the job description as below and let me know your interest. In case you are not looking for any change, I'd appreciate if you could refer any friends/ colleagues who might be interested in it. Direct Hire - Associate Director, Biostatistics - Neurology Jersey city, NJ This position supports the activities/projects in the Neurology Business Group including clinical study design and analysis, publications, as well as regulatory interactions. Essential Functions Reviews protocols and other study documents that are developed in collaborations of business alliances. Provides statistical supports for regulatory submissions in the collaborations. Independently reviews whole protocol and interfaces with clinicians and other functions to understand study requirements and study design elements including sample size calculations, analysis methods, study durations etc. for multiple studies. Develops and/or reviews statistical documents for multiple clinical trials, including SAPs, TLG shells and specifications of variable derivation. Support clinical trial related publications. Independently provides statistical and validation support for analysis datasets, statistical tables, figures and listings. Performs and validates statistical analysis. Independently reviews CSRs and performs data interpretation. Works with the internal/CRO statisticians and programmers to ensure the quality of CRO deliverables and on QA of data outputs. Functions as lead statistician in global registration trials and manages all related statistical activities. Leads preparation of inputs for regulatory documents and helps to prepare for meetings with health authorities. Leads preparation of responses to health authorities including identification and execution of new analysis required for responses. Manages contract statisticians in the group. Provides mentoring and oversees assigned work. Requirements PhD with 5+ years or MS with 10+ years of experience required in related discipline or in the pharmaceutical industry/CRO environment. Demonstrated excellence in statistical skills across multiple areas of pharmaceutical biostatistics, together with broad understanding and experience of the clinical development process. Experience with CRO oversight and FDA submission preferred. Excellent technical writing and verbal communication skills. Strong teamwork ability/commitment and individual initiative. Strong organizational skills with ability to effectively manage multiple studies. Excellent programming skills in SAS or R. - provided by Dice

Kellton Tech is a full-service software development company, offering end-to-end IT solutions, strategic technology consulting and product development services in Web, SMAC (Social, Mobile, Analytics, Cloud), ERP-BPM, and IoT space Our methodology of inventing infinite possibilities with technology helps us develop best in-class and cost effective solutions for our clients. Currently Kellton Tech is looking for talented resources for one of their listed clients. Below are further details on the positions: Role: IT Audit Senior Manager Location: Arlington, VA(till COVID Remote) Job Type: Contract to hire Duration: 6+ months contract to hire Visa: Only ==== with Secret Clearance(consultat whose clearance is not active but eligible for active again will consider for this role) Essential Duties: Lead day to day execution of IT related controls assurance or controls readiness projects associated with external audits, internal audits and service organization controls reports (e.g., SSAE 18). Interface with the client and understand a client's business and technology in order to identify, pursue, and ultimately win additional service opportunities. Help identify performance improvement opportunities for clients and lead client presentations. Ensure that all work products are complete, accurate and conform to defined standards. Manage and coach staff as they perform assessments to evaluate controls and execute audit procedures. Assist with proposals and business development calls. Federal Financial Statement Audit experience is required. Perform engagement management responsibilities, including performance reviews, task delegation, project scheduling, project financials, quality review and client management. Meet or exceed sales targets for new and follow-on work. Manage business development activities, such as proposals, capture, account teams, whitepapers, conferences, and/or other thought leadership materials. Meet or exceed targeted billing hours (utilization). Act as performance manager (coach) for up to four coaches outside of engagement responsibilities. Interview campus and/or experienced candidates. Qualifications: ====ship and fully adjudicated DoD Clearance at the SECRET level or higher. CPA, CIA, CISA, CISSP license/certification. Minimum 5 years of experience in one or more of the following capabilities: Auditing and/or Financial Reporting, FISCAM assessment and/or IT Audit and experience with FISCAM, DIACAP, FISMA, A-127, FFMIA, NIST SP 800-53. Knowledge of OMB A-123 documentation, testing, and reporting requirements. Ability to travel. Bachelor's Degree required from an accredited college or university in a related field. Ability to obtain and maintain certain job-related certifications if no job-related advanced degrees. U.S. citizenship may be required. Ability to work in the United States indefinitely required. Travel may be required. Coach and mentor junior staff members. Ability to work overtime required on occasion. Ability to sit in an office environment for long periods of time. Ability to obtain and maintain a security clearance. Ability to communicate clearly in writing and verbally. Ability to obtain and maintain firm independence and abide by firm ethics requirements. Meet or exceed continuing professional education (CPE) requirements. For more information please contact Shaik Naveed ( ) or Ph ext 1050. Thank you for all your time! - provided by Dice