Senior Biostatistical Programming Lead

7 days ago

Philadelphia, Pennsylvania, United States Kaztronix Full time
Job Summary

The Lead Biostatistical Programmer I - III position at Kaztronix requires expertise in processing clinical data for statistical analysis of Phase I - III clinical trials, with a focus on leading project teams.

Key Responsibilities
  • Conduct statistical programming work of clinical data using SAS Software.
  • Ensure that all programs, outputs, and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs.
  • Generate analysis datasets according to CDISC standard and SAP.
  • Implement analysis methods according to SAP, and produce summary tables, graphs, and data listings using SAS; Conduct adhoc analyses.
  • Validate programs and associated results produced by other programming colleagues.
  • Participate in TLF shell preparation and review, and assist statistician for SAP preparation.
  • Run CDISC validation programs e.g. OpenCDISC reports to ensure ADaM datasets are CDISC compliant.
  • Develop standard SAS macros for efficient analyses of clinical data supervised by Programming management.
  • Participate in the review of 'Statistical Analysis Plan' and other documents essential to the conduct of statistical programming work for clinical trials.
  • Work with Clinical Research Organizations, as required, to participate in the oversight and management of programming activities to help ensure quality, timeline, and deliverable are met.
  • Work independently to program for individual studies with minimum supervision.
  • Function as a Lead programmer for a compound or a group of studies performing the following functions:
    • Maintain the overall timeline for his/her studies.
    • Maintain the programming standards for his/her studies.
    • Review standard macros used.
    • Review standard datasets used.
    • Discuss need for programming resources for their group of studies.
    • Mentor/Train junior programmers on Incyte systems and standards as they work on studies within their area.
    • Assist junior programmers in new study set-up to help identify similar studies.
    • Review Production area after study programming is complete to make sure datasets, programs, and outputs are properly stored.
    • Check that the validation summary reports are clean of errors and warnings, and show proper documentation of SAS programs.
    • Review individual study CDISC validation output.
  • Act as a Programming lead for a submission project under supervision of Programming management.
Requirements
  • BA/BS degree in mathematics, statistics, computer science, or health-related field.
  • Minimum 5 years of programming experience using SAS Base/Stat/Macro/GRAPH in the biopharmaceutical and/or CRO industries; a MS in statistics or computer sciences is desired.
  • Data Management experience and knowledge of CDISC standard are highly desirable.
  • Good SAS programming skills and attention to detail are essential.
  • Demonstrate knowledge of regulatory biostatistics, SOPs, and guidelines.
  • Highly motivated and able to work well independently.
  • Strong organizational, time management, communication, and project coordination and leadership skills.
  • Must be able to work well under timeline pressure.
  • Must be able to work on multiple tasks while coordinating others at the same time.

  • Senior Statistical Analyst, PK/PD

    2 weeks ago

    Philadelphia, Pennsylvania, United States IQVIA Full time

    Key Responsibilities:• Collaborate with cross-functional teams of scientists, clinical researchers, and biostatisticians to design, execute, and analyze clinical trials for pharmaceutical and biotech companies.• Utilize expertise in pharmacokinetics (PK) and pharmacodynamics (PD) to develop and implement statistical models and simulations for data...

  • Senior Project Lead

    6 hours ago

    Philadelphia, Pennsylvania, United States Athena Global Advisors Full time

    Athena Global Advisors is seeking an experienced Senior Project Lead to join our team in Philadelphia, PA. This role offers a salary range of $110,000 - $140,000 per year, depending on experience.Job Description:We are looking for a skilled project management professional with a strong understanding of the Broadband industry. The ideal candidate will have...

  • Research Scientist

    2 weeks ago

    Philadelphia, Pennsylvania, United States The University of Pennsylvania Full time

    Job Title: Research ScientistJob SummaryWe are seeking a highly skilled Research Scientist to join our team at The University of Pennsylvania. As a Research Scientist, you will be responsible for conducting research in epidemiology and biostatistics, with a focus on pediatric oncology. You will work under the direction of the principal investigator to...

  • Senior Care Professional

    3 weeks ago

    Philadelphia, Pennsylvania, United States Discovery Senior Living Full time

    Resident Care Specialist Role at Discovery Senior LivingJob SummaryDiscovery Senior Living is seeking a Resident Care Specialist to join our team in the northeast region. The successful candidate will be responsible for supporting the overall operation of our Resident Care Department, ensuring clinical, regulatory, and financial expectations are met.Key...

  • Lead Research Program Director

    6 hours ago

    Philadelphia, Pennsylvania, United States Perelman School of Medicine University of Pennsylvania Full time

    Perelman School of Medicine University of Pennsylvania seeks a highly skilled and experienced Research Program Director to join our team. This is an exceptional opportunity for a talented individual to lead our research initiatives and make a significant impact in the field of genetics.Job SummaryThe Research Program Director will be responsible for...

  • Clinical Research Statistician

    4 weeks ago

    Philadelphia, Pennsylvania, United States ACE Partners Full time

    Key ResponsibilitiesStudy Design & Statistical Planning: Collaborate with clinical teams to design studies, including sample size calculations, randomization plans, and statistical methodology to ensure scientifically sound trials.Statistical Analysis: Perform and oversee statistical analyses of clinical trial data, ensuring adherence to regulatory standards...

  • Program Leadership Coordinator

    2 weeks ago

    Philadelphia, Pennsylvania, United States College Possible Leadership Team Full time

    Drive Student Success with College PossibleCollege Possible is seeking an experienced Program Leadership Coordinator to join our dynamic team. As a key member of our leadership team, you will oversee the adaptation and implementation of College Possible programming to ensure high-quality initiatives and projects at the site level.Responsibilities:Program...

  • Senior Software Engineer

    4 weeks ago

    Philadelphia, Pennsylvania, United States KickUp Full time

    About the RoleKickUp is seeking a skilled Senior Software Engineer to lead the development of our professional growth platform. As a technical lead, you will be responsible for building a modern platform that empowers educator growth, collaborating closely with product managers and designers, and serving in a role of technical leadership. You will work...

  • Senior Software Engineer

    2 weeks ago

    Philadelphia, Pennsylvania, United States Kick Up Full time

    KickUp is looking for a Senior Software Engineer to join our team of innovators.We are a remote-first organization with a high degree of flexibility.Our team is dedicated to creating a robust, data-rich professional growth platform.We are committed to growth and encourage applications from individuals who meet a majority of the qualifications.About the...

  • Senior Web Development Manager

    4 weeks ago

    Philadelphia, Pennsylvania, United States Bluecadet Full time

    Job Title: Senior Web Development ManagerJob Summary:We are seeking a highly skilled Senior Web Development Manager to join our team at Bluecadet. As a key member of our web development team, you will be responsible for leading the development of complex web applications and ensuring that our high-quality standards are met.Key Responsibilities:Lead a team of...

  • Senior Distribution Engineer Lead

    7 days ago

    Philadelphia, Pennsylvania, United States Leidos Full time

    About LeidosAt Leidos, we pride ourselves on being a trusted and technology-focused solutions provider. Our Power Delivery Services Team is the go-to for utilities and mobile operators who need reliable power and telecommunication expertise.Salary and BenefitsThe estimated salary for this role ranges from $87,100 to $157,450 per year, with additional...

  • Senior Living Cook

    1 month ago

    Philadelphia, Pennsylvania, United States Simpson Full time

    Job DetailsJob Title: Senior Living CookJob Summary: We are seeking an experienced Cook to join our team at Simpson, a leading provider of senior living services. As a Cook, you will play a vital role in preparing and serving nutritious meals to our residents, ensuring a pleasant dining experience.Key Responsibilities:Prepare and cook meals according to...

  • Lead Civil Engineer

    6 hours ago

    Philadelphia, Pennsylvania, United States WSP Full time

    Job DescriptionJob Title: Lead Civil EngineerJob Summary: We are seeking a highly skilled Lead Civil Engineer to join our team at WSP. The successful candidate will be responsible for leading technical design programs, facilitating client engagement sessions, and reinforcing internal design standards.Key Responsibilities:Lead technical design programs for...

  • Senior Creative Director

    1 month ago

    Philadelphia, Pennsylvania, United States Anthropologie Full time

    Senior DesignerAnthropologie is seeking a Senior Designer to lead and grow the Lounge apparel business. This role will contribute to the overall trend and direction for designs each season, and actively participate in designing seasonal collections.The Senior Designer will supervise Associate/Assistant Designers to ensure that designs and resulting product...

  • Senior Account Director

    1 month ago

    Philadelphia, Pennsylvania, United States Digitas Health Full time

    Job Title: Vice President, Account DirectorDigitas Health is seeking a seasoned professional to join our team as a Vice President, Account Director. In this role, you will be responsible for managing client relationships, partnering with senior leadership on high-level strategy, and leveraging your expertise to drive business growth.Key...

  • Senior .NET Technical Lead

    4 weeks ago

    Philadelphia, Pennsylvania, United States Pyramid Consulting, Inc Full time

    Job Description for .NET Technical LeadImmediate Opportunity for a .NET Technical LeadWe are seeking a highly skilled and experienced .NET Technical Lead to join our team at Pyramid Consulting, Inc. This is a contract opportunity with a potential for long-term engagement and is located in the Philadelphia area (Hybrid).Key Responsibilities:Lead and mentor...

  • Lead Bridge Design Engineer

    2 weeks ago

    Philadelphia, Pennsylvania, United States HARDESTY & HANOVER Full time

    Job OverviewHARDESTY & HANOVER, a trusted full-service infrastructure engineering firm, is seeking an experienced Lead Bridge Design Engineer to join our Rail & Transit Group in Philadelphia, PA.As a Senior Structural Engineer with a growing practice, you will lead the design of simple and complex fixed bridges, movable bridges, and perform bridge...

  • Senior SCADA Automation Engineer

    4 weeks ago

    Philadelphia, Pennsylvania, United States Jobot Full time

    Key ResponsibilitiesThe Senior SCADA Automation Engineer will lead technical design for the SCADA engineering group. This role will also act as an Owner's Engineer for projects produced by contractors.Lead the preparation and review of Functional Design Specifications based on customer requirements.Lead the design of power system automation control logics...

  • Business Development Manager Lead

    4 weeks ago

    Philadelphia, Pennsylvania, United States Invictus Talent Solutions Full time

    Business Development Manager Responsibilities:As a Senior Business Development Manager at Invictus Talent Solutions, you will be responsible for creating and monitoring target accounts and relationships for the local sales department. This role requires leadership and production experience in IT Staffing Sales, with a focus on bringing in new accounts and...

  • Assistant Group Supervisor

    2 weeks ago

    Philadelphia, Pennsylvania, United States Episcopal Community Services Full time

    Job SummaryWe are seeking a dedicated and experienced Assistant Group Supervisor to join our Out of School Time (OST) program team at Episcopal Community Services. As a key member of our staff, you will play a vital role in providing a safe and nurturing environment for children and youth, supporting their academic and personal development.The OST program is...