Senior Statistical Programming Lead

2 weeks ago

Durham, North Carolina, United States 5PY US Quintiles, Inc. Full time

Location: Remote work available across the United States

Objective:

Become a vital member of our FSP team. In this capacity, you will orchestrate and oversee the creation of comprehensive programming solutions that address a wide array of statistical programming requirements. You will offer technical guidance and leadership within the department, as well as provide internal consulting services that include specifications and user needs analysis for intricate project or client demands.

Position Details:

  • Title: Senior Statistical Programming Lead
  • Remote Position
  • Minimum of 4 years of experience in the CRO/Pharmaceutical sector
  • Relevant Therapeutic Areas: Oncology, Immunology, Infectious Diseases, and Early Development Clinical Programs

Essential Skills:

  • Proficient in R programming alongside SAS Base, with a solid understanding of SAS Graph and SAS Macros.
  • Adept at executing advanced statistical methods as per the specifications provided by biostatisticians.
  • Comprehensive knowledge of CDISC standards (SDTM and ADaM).
  • Strong grasp of relational database concepts and theories.
  • Exceptional application development capabilities.
  • In-depth understanding of clinical trial data, with hands-on experience in data manipulation, analysis, and reporting.
  • Familiarity with ICH E6, ICH E3, ICH E8, ICH E9, and clinical research methodologies.
  • At least 4 years of experience in Statistical Programming within the pharmaceutical or medical device industries.
  • Strong verbal and written communication abilities.
  • Capacity to manage multiple projects, effectively plan, organize, and prioritize tasks.

Required Knowledge, Skills, and Abilities:

  • Experience in a technical team leadership role, directly engaging clients and coordinating tasks within a programming team.
  • Thorough understanding of clinical research regulatory standards, including Good Clinical Practice (GCP) and ICH guidelines.
  • Knowledge of statistics, programming, and the clinical drug development process.
  • Advanced proficiency in R programming.
  • Expertise in Base SAS, SAS/STAT, SAS Graph, and SAS Macro Language.
  • Experience with SDTM and ADaM implementations according to CDISC standards.
  • Strong organizational, interpersonal, leadership, and communication skills.
  • Ability to independently manage multiple tasks and projects.
  • Capability to delegate tasks to other members of the Statistical Programming team.
  • Exceptional attention to detail and accuracy.
  • Ability to lead teams and projects, managing at a group level.
  • Recognizes when negotiation skills are necessary and seeks assistance when needed.
  • Ability to establish and maintain effective working relationships with colleagues, management, and clients.

Key Responsibilities:

  • Plan, coordinate, and execute the following for complex studies: (i) programming, testing, and documentation of statistical programs for generating statistical tables, figures, and listings; (ii) programming of analysis datasets (derived datasets) and transfer files for both internal and external clients; (iii) programming quality control checks for source data and periodically reporting data issues.
  • Interpret project-level requirements and develop programming specifications for complex studies.
  • Provide advanced technical expertise in collaboration with internal and external clients, independently delivering project solutions to Statistical Programming teams and the department for complex studies.
  • Fulfill project responsibilities as a technical team lead for individual complex studies or groups of studies.
  • Communicate directly with internal and client statisticians and clinical team members to ensure a clear understanding of requirements and project timelines.
  • Estimate programming scope of work, manage resource assignments, communicate project status, and negotiate/re-negotiate project timelines for deliverables.
  • Utilize and advocate for established standards, SOPs, and best practices.
  • Provide training and mentorship to Statistical Programming team members and department staff.

Minimum Required Education and Experience:

  • Bachelor's degree from a reputable university, preferably in a science or mathematics-related field.

5PY US Quintiles, Inc. is a prominent global provider of advanced analytics, technology solutions, and clinical research services to the life sciences sector. We are dedicated to pushing the boundaries of human science and data science to create significant impacts, helping our clients foster a healthier world.

We are committed to ensuring equal employment opportunities for all, including veterans and candidates with disabilities.

5PY US Quintiles, Inc. requires compliance with specific COVID-19 vaccination status for certain roles.

The potential base pay range for this position, when annualized, is $117,000 to $218,000. Actual base pay may vary based on various factors, including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Depending on the position, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare benefits.

  • Lead Statistical Analyst

    2 weeks ago

    Durham, North Carolina, United States 5PY US Quintiles, Inc. Full time

    This role is a remote, full-time opportunity. Candidates must reside in either the United States or Canada.About 5PY US Quintiles, Inc.5PY US Quintiles, Inc. is a prominent entity within the clinical research sector, dedicated to delivering comprehensive resources through a Functional Service Provider (FSP) partnership. This structure allows you to enjoy the...

  • Senior Biostatistics Lead

    1 day ago

    Durham, North Carolina, United States SDC (Statistics & Data Corporation) Full time

    About SDC (Statistics & Data Corporation)SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Our purpose is to partner with sponsors to provide high-quality and experienced team members to develop great medicines that...

  • Senior Clinical Data Programmer

    5 days ago

    Durham, North Carolina, United States IQVIA Full time

    About the Role:IQVIA is seeking a highly skilled Senior Clinical Data Programmer to join our team. As a key member of our data management team, you will be responsible for ensuring the quality and accuracy of EDC build processes.Key Responsibilities:Collaborate with peers, data management, and statistics to ensure the quality and accuracy of EDC build...

  • Senior Technical Program Manager

    3 months ago

    Durham, North Carolina, United States Digital Turbine Full time

    At Digital Turbine, we make mobile advertising experiences more meaningful and rewarding for users, app publishers, and advertisers — intelligently connecting people in more ways, across more devices. We provide app publishers and advertisers with powerful ads and experiences that captivate consumers, fuel performance, and help telecoms and OEMs...

  • Program Coordinator/Senior Program Manager

    5 days ago

    Durham, North Carolina, United States Residential Services Inc. Full time

    Job SummaryWe are seeking a highly motivated and experienced Program Coordinator/Senior Program Manager to join our team at Residential Services Inc. as a Supervisor of Residential Services.Key ResponsibilitiesCoordinate the development of residents' ongoing daily schedules within a group home setting according to their Individual Support Plans.Provide...

  • Senior Program Coordinator

    2 weeks ago

    Durham, North Carolina, United States City of Durham Full time

    Position Title: Senior Program Coordinator - Child Care ServicesSalary: $21.81 HourlyJob Type: Part-Time (Less than 20 hours per week)Department: Parks and RecreationPosition Overview:Join the dedicated team at the City of Durham, where your work will contribute to enhancing community well-being through effective child care programs. Our accredited...

  • Senior Living Activities Manager

    2 weeks ago

    Durham, North Carolina, United States Navion Senior Solutions Full time

    Job OverviewNavion Senior Solutions is seeking a dedicated Life Enrichment Coordinator to enhance the quality of life for our residents. This role is pivotal in developing and overseeing our Daily Life Enrichment initiatives tailored for Assisted Living and Memory Care residents.Key Responsibilities:Lead and implement engaging programs that promote social...

  • Senior Process Engineer III

    2 days ago

    Durham, North Carolina, United States Compunnel Inc. Full time

    Job Summary:We are seeking a highly skilled Senior Process Engineer III to lead and innovate in our dynamic team. As a key member of our manufacturing team, you will be responsible for providing hands-on support for the installation, start-up, and debugging of cutting-edge cable manufacturing equipment.Key Responsibilities:Provide technical expertise to...

  • Senior Program Manager Position

    5 days ago

    Durham, North Carolina, United States General Dynamics Information Technology Full time

    Job SummaryGeneral Dynamics Information Technology (GDIT) is seeking a highly experienced Senior Program Manager to lead a High Performance Computing contract. As a key member of our team, you will be responsible for providing management, direction, administration, QA, and leadership of the contract execution.Key ResponsibilitiesProvide technical advice and...

  • Lead Business Analytics Specialist

    2 weeks ago

    Durham, North Carolina, United States Avalara Full time

    Role OverviewAvalara is on the lookout for a business-oriented Lead Business Analytics Specialist to become a vital part of our Global Analytics and Insights team. Reporting directly to the Director of Business and Customer Analytics, you will deliver analytical insights that facilitate the implementation of best practices in customer lifecycle management....

  • Senior Research Scientist

    5 days ago

    Durham, North Carolina, United States Teledyne Scientific & Imaging, LLC Full time

    Job SummaryWe are seeking a highly skilled Senior Research Scientist to join our team at Teledyne Scientific & Imaging, LLC. As a key member of our research team, you will be responsible for driving strategic direction, program capture, and research and development tasks related to machine learning, signal processing, and other advanced technology...

  • Data Management and Biostatistics Expert

    5 days ago

    Durham, North Carolina, United States IQVIA Full time

    About the RoleWe are seeking a highly skilled Senior Clinical Data Programmer to join our team at IQVIA. As a key member of our Data Management and Biostatistics department, you will play a critical role in supporting our clients in the Rare Disease Biopharma industry.Key ResponsibilitiesCollaborate with peers, data management, and statistics teams to ensure...

  • Senior Electrical Engineer

    2 days ago

    Durham, North Carolina, United States GlaxoSmithKline Full time

    Job Summary:We are seeking a highly skilled and experienced Senior Electrical Engineer to lead our regional electrical engineering team. As a Regional Electrical Engineering Lead, you will be responsible for developing and delivering electrical strategies to support manufacturing activities across our sites.Key Responsibilities:Leadership and Team...

  • Assistant Manager

    5 days ago

    Durham, North Carolina, United States Charter Senior Living Full time

    Job SummaryWe are seeking a highly skilled and experienced Assistant Manager to join our team at Charter Senior Living. As an Assistant Manager, you will play a critical role in supporting the General Manager in the day-to-day operations of the facility.Key ResponsibilitiesSupervise and direct colleagues to ensure the smooth operation of the facility.Provide...

  • Test Engineering Lead

    5 days ago

    Durham, North Carolina, United States Zoetis Full time

    Job SummaryThe Senior Reliability Engineer will play a crucial role in ensuring the long-term performance of drug delivery and diagnostic devices in the animal health industry. This position will work as an independent contributor in creating new test methodologies, supporting existing test plans, and analyzing data to drive greater reliability for Zoetis...

  • Senior Technical Lead

    2 days ago

    Durham, North Carolina, United States Ampere Computing Full time

    About the RoleWe are seeking a highly experienced and skilled Senior Technical Lead to join our CPU Design team at Ampere Computing. As a key member of our team, you will be responsible for leading the development of high-performance CPU designs that meet the needs of our customers.Key ResponsibilitiesLead the design and development of CPU...

  • Senior Fitness Instructor

    5 days ago

    Durham, North Carolina, United States Calyx Living Full time

    Job SummaryCalyx Living is seeking a dynamic and experienced Senior Fitness Instructor to lead our wellness programs in a beautiful assisted living community in Durham. The ideal candidate will have a passion for teaching and a commitment to providing a safe and engaging environment for our residents.Key Responsibilities:Develop and lead a variety of fitness...

  • Zero-Cost Tech Fundamental Program

    2 months ago

    Durham, North Carolina, United States NPower Full time

    Tech Fundamentals is aFREE training program with virtual instruction.Program EligibilityWe are committed to serving those who need us the most. See if you qualify for our Tech Fundamentals program.If you are not a military veteran or spouse, the eligibility requirements are as follows:1826 years of ageHigh school diploma or equivalentLegally authorized to...

  • Senior Reliability Engineer

    3 days ago

    Durham, North Carolina, United States Zoetis Full time

    Job SummaryThe Senior Reliability Engineer will play a crucial role in ensuring the long-term performance of drug delivery and diagnostic devices in the animal health industry. This position will work independently to create new test methodologies, support existing test plans, and analyze data to drive greater reliability for Zoetis products.Key...

  • Senior Manager

    5 days ago

    Durham, North Carolina, United States LAB Labcorp Early Development Laboratories Inc. Full time

    Job SummaryWe are seeking a highly skilled Senior Manager to join our People Analytics team at LAB Labcorp Early Development Laboratories Inc. As a Senior Manager, you will be responsible for building and maintaining a comprehensive data analytics program that drives business outcomes and informs strategic decision-making.Key ResponsibilitiesData Analysis...