Talent.com
serp_jobs.error_messages.no_longer_accepting
Sr Principal R Programmer- PK / PD Expertise Required (NA Based)

Sr Principal R Programmer- PK / PD Expertise Required (NA Based)

Syneos Health / inVentiv Health Commercial LLCSanta Monica, CA, United States
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Sr Principal R Programmer- PK / PD Expertise Required (NA Based)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Responsibilities

  • Must be located in Canada or United states
  • Must have previous lead CRO experience within R and PK / PD studies.
  • Provides statistical programming technical support and expertise across the Biostatistics function and other departments as needed.
  • Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified inthe statistical analysis plan and programming specifications.
  • Proposes and leads the development of process improvements, programming tools and macros for standardization and efficiency, and the development of new concepts, technologies and products to meet emerging customer needs.
  • Analyzes information and develops innovative solutions to programming and data analysis challenges across the department.
  • Reviews, provides input, and promotes standardization of CRFs, databases, Statistical Analysis Plans and mock shells within a project or therapeutic area, or across a program.
  • Mentors other members of the Biometrics Department in the use of traditional, new, and novel approaches in delivering analytics to sponsors and regulatory agencies through the development and presentation of training courses and one on one discussion.
  • Understands and enforces compliance with company, regulatory, and industry standards, within and across projects or programs.
  • May develop or review specifications and may support any kind of statistical programming activity.
  • Negotiates and establishes accurate time estimates for completion of projects with internal team members and statistical programming management, provides regular status updates, and completes projects within agreed upon timeframe.
  • Maintains well organized, complete, and up-to-date project documentation, testing, and verification / quality control documents and programs ensuring inspection readiness.
  • May act as primary customer interface representing the department at client meetings; may present status updates at Senior Management meetings.
  • Displays willingness to work with others, holds project team members accountable, and leads projects and initiatives as necessary to meet the needs of the business.
  • May provide project oversight to Lead Statistical Programmers across one or more programs.
  • Maintains extensive working knowledge of clinical drug development, industry standards, and electronic submission requirements.
  • Actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. May contribute to presentations at industry conferences and roundtables.
  • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML)
  • May lead or support the development of Standard Operating Procedures (SOPs), guidelines, policies, and / or procedures; Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
  • Supports business development activities by contributing to proposals, requests for information, budgets, and attending sponsor bid defense meetings
  • Performs other work-related duties as assigned.
  • Minimal travel may be required.
  • Qualifications

  • PK / PD and R are Required
  • Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated technical expertise in programming.
  • Participation in publications or presentations in areas relevant to programming or industry standards is preferred.
  • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment, as demonstrated by the ability to develop tools or lead multiple complex and / or global projects with teams of statistical programmers; and effectively work across functional lines to accomplish company-wide goals.
  • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements.
  • Experience in submissions to a regulatory agency preferred.
  • Experience in mentoring others in clinical trial process and CDISC Standards.
  • Excellent communication, presentation, and interpersonal skills, both written and verbal, with an ability to inform, influence, convince, and persuade.
  • Ability to read, write, speak, and understand English.
  • At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions / bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

    Salary Range :

    $114,000.00 - $210,900.00

    The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

    Get to know Syneos Health

    Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

    No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

    http : / / www.syneoshealth.com

    Additional Information

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

    serp_jobs.job_alerts.create_a_job

    Principal Principal • Santa Monica, CA, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Epic PB Analyst

    Epic PB Analyst

    VirtualVocationsFullerton, California, United States
    serp_jobs.job_card.temporary
    A company is looking for an Epic PB Analyst for a 6+ month contract position.Key Responsibilities Mentor and guide client builders in environments with limited system access Provide hands-on bui...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Statistical Programmer Consultant

    Statistical Programmer Consultant

    VirtualVocationsFullerton, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Statistical Programmer Consultant.Key Responsibilities Provide programming support for Phase 1 to Phase 3 studies, including project integration and disease monitoring ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Computer Programmer

    Computer Programmer

    Hvantage Technologies, Inc.Canoga Park, CA, US
    serp_jobs.job_card.full_time
    POSITION : Computer Programmer DUTIES : Manage large cloud applications for the healthcare domain.Manage large enterprise software development projects with substantial contribution on architecture a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Tools Programmer

    Tools Programmer

    VirtualVocationsOrange, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Tools Programmer to join a team developing a new console-focused racing title.Key Responsibilities Develop and maintain tools for converting and importing track and geo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Principal AI Architect

    Principal AI Architect

    VirtualVocationsSignal Hill, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Principal Agentic AI Architect to define and operationalize their approach to agentic AI at scale. Key Responsibilities Translate high-level AI vision into a measurable ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    End-Point Engineer, Principal

    End-Point Engineer, Principal

    JobotLos Angeles, CA, US
    serp_jobs.job_card.full_time
    End-Point Engineer opportunity!!.This Jobot Consulting Job is hosted by : Robert Reyes.Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary : $138,000 - ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Lead Programmer

    Lead Programmer

    VirtualVocationsSignal Hill, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Lead Programmer.Key Responsibilities Manipulate large databases and generate reports for healthcare data analysis Monitor and assess FSP programmers' workload and over...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Epic Beaker Build Advisor

    Epic Beaker Build Advisor

    VirtualVocationsWhittier, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Beaker Laboratory Build Advisor for Epic Implementation.Key Responsibilities Evaluate the current Beaker build, workflows, and configuration to identify areas for impro...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    PE Licensed Director of Engineering

    PE Licensed Director of Engineering

    VirtualVocationsLong Beach, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director of Engineering.Key Responsibilities Oversee project management and resource planning to ensure project success and profitability Mentor and manage technical t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    TMS Applications Programmer III

    TMS Applications Programmer III

    University of California - Los Angeles HealthLos Angeles, CA, United States
    serp_jobs.job_card.full_time
    The Neuromodulation Division at UCLA Health is seeking an experienced Applications Programmer III to lead the design, development, and management of complex clinical, research, and business softwa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Statistical Programmer

    Senior Statistical Programmer

    VirtualVocationsGarden Grove, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Statistical Programmer - ADaM Data Standards to join a remote team focused on ADaM Oncology standards. Key Responsibilities Lead the development and maintenance o...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Applications Programmer

    Senior Applications Programmer

    VirtualVocationsPasadena, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Applications Programmer to serve as the Sustainment Lead or Subject Matter Expert in sustainment life cycle management activities. Key Responsibilities Analyze fu...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director of AI

    Director of AI

    VirtualVocationsCarson, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director of AI.Key Responsibilities Develop and execute the AI strategy, aligning it with business goals and market trends Lead and inspire a team of AI researchers an...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Bioinformatics Programmer Analyst

    Bioinformatics Programmer Analyst

    VirtualVocationsGarden Grove, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Programmer Analyst (Bioinformatics).Key Responsibilities Create, execute, maintain, and validate programs for data transfer and integration Develop visualizatio...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Senior Programmer

    Senior Programmer

    VirtualVocationsBurbank, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Programmer to support long-term remote FSP projects.Key Responsibilities Manipulate large databases and generate reports for healthcare data analysis Create com...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Principal Software Architect

    Principal Software Architect

    VirtualVocationsSignal Hill, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a Principal Software Architect- GenAI.Key Responsibilities Lead architectural decisions and represent the GenAI domain area Provide technical leadership and support to m...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    C++ Programming Tutor

    C++ Programming Tutor

    Tutor Me EducationSanta Monica, CA, US
    serp_jobs.job_card.part_time
    serp_jobs.filters_job_card.quick_apply
    Tutor Me Education is reshaping how students learn.We are looking for teachers and tutors with.Mon / Wed Mornings & Tues / Thurs after 11 : 30am, Fridays are open. We are looking for a patient & u...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    SAP ECC PM / IM Subject Matter Expert

    SAP ECC PM / IM Subject Matter Expert

    VirtualVocationsGarden Grove, California, United States
    serp_jobs.job_card.full_time
    A company is looking for an SAP ECC SME (PM / IM).Key Responsibilities Lead the end-to-end design, configuration, and activation of SAP ECC PM and IM modules Collaborate with plant and maintenance...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Primary Care Physician, Calabasas

    Primary Care Physician, Calabasas

    UCLA HealthCalabasas, US
    serp_jobs.job_card.full_time
    As a Primary Care Physician with UCLA Health, U can enjoy the close connection of community-focused patient care with the resources and reputation of one of the nation’s leading health system...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    VP, GM Products, AI

    VP, GM Products, AI

    VirtualVocationsNorwalk, California, United States
    serp_jobs.job_card.full_time
    A company is looking for a VP, GM Products, AI and Core Platform.Key Responsibilities Drive the vision, execution, and growth of the cloud and knowledge platform portfolio Engage with market buy...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours