Job Description: Responsible for providing support to technical professionals with regard to a variety of administrative, systems, and business operations problems, and participation in related system development projects of moderate to complex nature. Responsibilities may include determining and defining system specifications, process improvement, quality assurance, interaction with customers and technical staff, and higher emphasis on problem resolution. Requires strong interpersonal and communication skills, increased level of business knowledge and experience in a defined area (i.e. claims, membership, accounting, service, finance, etc.), and experience and knowledge of project methodology and the application development life-cycle. Position requires knowledge of various technologies including legacy, client/server, or web-based technologies, rational tools knowledge (ClearQuest, ReqPro, etc.) and RUP methodology and 3-5 years of related experienced as outlined above. Qualifications: Excellent Analytical Skills Perform independent research Be able to self-train on existing (in house) tools / processes Elicit Requirements: Asking questions until the requirement is known Reiterating the 'ask' back to the Customer to ensure correct interpretation Documenting Requirements: Experience with documenting Business Requirements Microsoft Office Experience: Must have Excel expertise (looking for advanced) SQL Queries: Basic SQL query skills including joins; group by Data Models Understanding how Tables relate to each other Primary Keys / Foreign Keys Additional Preferred Qualifications: Health Care Knowledge Health Care Product Knowledge ICIS / PTC Knowledge - provided by Dice
10/01/2020
Full time
Job Description: Responsible for providing support to technical professionals with regard to a variety of administrative, systems, and business operations problems, and participation in related system development projects of moderate to complex nature. Responsibilities may include determining and defining system specifications, process improvement, quality assurance, interaction with customers and technical staff, and higher emphasis on problem resolution. Requires strong interpersonal and communication skills, increased level of business knowledge and experience in a defined area (i.e. claims, membership, accounting, service, finance, etc.), and experience and knowledge of project methodology and the application development life-cycle. Position requires knowledge of various technologies including legacy, client/server, or web-based technologies, rational tools knowledge (ClearQuest, ReqPro, etc.) and RUP methodology and 3-5 years of related experienced as outlined above. Qualifications: Excellent Analytical Skills Perform independent research Be able to self-train on existing (in house) tools / processes Elicit Requirements: Asking questions until the requirement is known Reiterating the 'ask' back to the Customer to ensure correct interpretation Documenting Requirements: Experience with documenting Business Requirements Microsoft Office Experience: Must have Excel expertise (looking for advanced) SQL Queries: Basic SQL query skills including joins; group by Data Models Understanding how Tables relate to each other Primary Keys / Foreign Keys Additional Preferred Qualifications: Health Care Knowledge Health Care Product Knowledge ICIS / PTC Knowledge - provided by Dice
Contract job working for my company. The job will be on site when the site opens back up. Must be able to work for my company directly. EZ3385 Senior Biostatistician duration 1 year rate $80 - $90 hr. W2. 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
10/01/2020
Full time
Contract job working for my company. The job will be on site when the site opens back up. Must be able to work for my company directly. EZ3385 Senior Biostatistician duration 1 year rate $80 - $90 hr. W2. 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
Direct hire, Permanent job E3389 Associate Director, Biostatistics - Neurology Salary Starting base salary range: $150,000 Bonus range: 16-20% Eisai Relocation is available for great candidates Location 100 Tice Blvd., Woodcliff Lake, NJ 07677 Highlights from Job Description and Additional Info.: • Eisai seeks pharma and biotech industry-experienced candidates. • This position will support an important lemborexant initiative for Eisai. • Preferred candidates will show a history of being promoted at their companies. • Seeking candidates with excellent interpersonal skills and who have been very well-regarded at their companies. • See the job description for additional details and requirements. Associate Director, Biostatistics - Neurology Job Summary 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
10/01/2020
Full time
Direct hire, Permanent job E3389 Associate Director, Biostatistics - Neurology Salary Starting base salary range: $150,000 Bonus range: 16-20% Eisai Relocation is available for great candidates Location 100 Tice Blvd., Woodcliff Lake, NJ 07677 Highlights from Job Description and Additional Info.: • Eisai seeks pharma and biotech industry-experienced candidates. • This position will support an important lemborexant initiative for Eisai. • Preferred candidates will show a history of being promoted at their companies. • Seeking candidates with excellent interpersonal skills and who have been very well-regarded at their companies. • See the job description for additional details and requirements. Associate Director, Biostatistics - Neurology Job Summary 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
Primary Responsibilities/Duties: Works directly with business unit clients to understand specific data analytics and business process needs; manages scope definition and expectations to secure alignment between business unit clients and technical teams. Translate business requirements into functional specifications, guides team of tester on test planning, scenario planning test outcomes and coordinates UAT between technical team and business unit clients. Prepare and present scope, detailed timelines estimates, impact assessments and project tracking report to Patient Services Data Leads. Coordinates with external vendors to document and report scope, timelines and estimates and integrates inputs into overall solution implementation plan. Works with cross functional team to identify and collate dependencies, risks and issues. Clearly articulates that to affected teams and devises plans to address above. Demonstrable experience in Project / Program Management, Business Analysis, Data Quality testing and test planning. Ability to communicate effectively with both technical and business teams. Work with minimal oversight; deliverables and relationships are monitored through periodic reviews. Understand and manage projects according to applicable Policies and procedures. Strong MS office and/or MS Project skills. Experience of Relational Databases like Teradata, Big Data technologies (Hadoop, Cloudera), Query tools (SQL, HUE, R, SAS, Python) is preferred Years of experience/education and/or certifcations required: 7+ years experience What are the top 3-5 skills requirements should this person have? Must have excellent written communication as well as interpersonal skills Some project management skills is helpful, but must have strong organizational skills Must be driven, willing to take initiative and strong self starter Strong delivery and execution skills (versus planning and strategy) SLC experience What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Pharma experience Experience of Relational Databases like Teradata, Big Data technologies (Hadoop, Cloudera), Query tools (SQL, HUE, R, SAS, Python) is preferred PMP certification a plus Degree preferred not required - provided by Dice
09/29/2020
Full time
Primary Responsibilities/Duties: Works directly with business unit clients to understand specific data analytics and business process needs; manages scope definition and expectations to secure alignment between business unit clients and technical teams. Translate business requirements into functional specifications, guides team of tester on test planning, scenario planning test outcomes and coordinates UAT between technical team and business unit clients. Prepare and present scope, detailed timelines estimates, impact assessments and project tracking report to Patient Services Data Leads. Coordinates with external vendors to document and report scope, timelines and estimates and integrates inputs into overall solution implementation plan. Works with cross functional team to identify and collate dependencies, risks and issues. Clearly articulates that to affected teams and devises plans to address above. Demonstrable experience in Project / Program Management, Business Analysis, Data Quality testing and test planning. Ability to communicate effectively with both technical and business teams. Work with minimal oversight; deliverables and relationships are monitored through periodic reviews. Understand and manage projects according to applicable Policies and procedures. Strong MS office and/or MS Project skills. Experience of Relational Databases like Teradata, Big Data technologies (Hadoop, Cloudera), Query tools (SQL, HUE, R, SAS, Python) is preferred Years of experience/education and/or certifcations required: 7+ years experience What are the top 3-5 skills requirements should this person have? Must have excellent written communication as well as interpersonal skills Some project management skills is helpful, but must have strong organizational skills Must be driven, willing to take initiative and strong self starter Strong delivery and execution skills (versus planning and strategy) SLC experience What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification? Pharma experience Experience of Relational Databases like Teradata, Big Data technologies (Hadoop, Cloudera), Query tools (SQL, HUE, R, SAS, Python) is preferred PMP certification a plus Degree preferred not required - provided by Dice