Talent.com
Principal Statistical (R) Programmer (North America Only)
Principal Statistical (R) Programmer (North America Only)Syneos Health/ inVentiv Health Commercial LLC • Charleston, SC, United States
Principal Statistical (R) Programmer (North America Only)

Principal Statistical (R) Programmer (North America Only)

Syneos Health / inVentiv Health Commercial LLC • Charleston, SC, United States
[job_card.1_day_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Principal Statistical (R) Programmer (North America Only)

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

  • Previous Industry Experience within R is required.
  • Must be eligible to work within North America without Sponsorship. Only hiring in North America for this position.
  • Uses R, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements.
  • Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings.
  • Keeps project team members informed of programming progress and issues requiring their attention.
  • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
  • Maintains well organized, complete, and up-to-date project documentation, testing, and verification / quality control documents and programs ensuring inspection readiness.
  • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
  • Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor / requestor with little rework.
  • Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.
  • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
  • Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions.
  • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables.
  • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.
  • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.
  • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.
  • Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions.
  • Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and / or procedures.
  • Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.
  • When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards
  • 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)
  • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards.
  • Transfers deliverables.
  • Performs other work-related duties as assigned.
  • Minimal travel may be required
  • Qualifications :

  • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience.
  • Extensive programming experience in SAS and R or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and / or global projects with teams of statistical programmers.
  • 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 written and verbal communication skills.
  • 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 :

    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.

    [job_alerts.create_a_job]

    Principal Statistical R Programmer North America Only • Charleston, SC, United States

    [internal_linking.similar_jobs]
    Physician (MD / DO) - Perinatology in West Columbia, SC

    Physician (MD / DO) - Perinatology in West Columbia, SC

    LocumJobsOnline • North Charleston, South Carolina, US
    [job_card.full_time] +1
    Doctor of Medicine | Perinatology.Competitive weekly pay (inquire for details) .LocumJobsOnline is working with CompHealth to find a qualified Perinatology MD in West Columbia, South Carolina, 2916...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Physician (MD / DO) - Hematology and Oncology in West Columbia, SC

    Physician (MD / DO) - Hematology and Oncology in West Columbia, SC

    LocumJobsOnline • North Charleston, South Carolina, US
    [job_card.full_time] +1
    Doctor of Medicine | Hematology and Oncology.Competitive weekly pay (inquire for details) .LocumJobsOnline is working with CompHealth to find a qualified Hematology and Oncology MD in West Columbia...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Radiology Tech - $1,987 per week in Charleston, SC

    Travel Radiology Tech - $1,987 per week in Charleston, SC

    AlliedTravelCareers • North Charleston, South Carolina, US
    [job_card.full_time]
    AlliedTravelCareers is working with Prime HealthCare Staffing to find a qualified Rad Tech in Charleston, South Carolina, 29425!. Prime HealthCare Staffing, a national health care staffing company w...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel EP Tech / EP Lab Tech - $2,050 to $2,291 per week in Charleston, SC

    Travel EP Tech / EP Lab Tech - $2,050 to $2,291 per week in Charleston, SC

    AlliedTravelCareers • North Charleston, South Carolina, US
    [job_card.full_time]
    AlliedTravelCareers is working with Prime Time Healthcare to find a qualified Electrophysiology Tech in Charleston, South Carolina, 29401!. Now Hiring : Allied Healthcare EP - Charleston, SC.Contact ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Physician PRN

    Physician PRN

    Concentra • Charleston, South Carolina, US
    [job_card.full_time]
    Job Description Job Description Overview Are you ready to take your career to new heights? At Concentra, you will be a vital member of our patient care team and play a crucial role in providing e...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Endocrinologist | Coastal Charleston, SC

    Endocrinologist | Coastal Charleston, SC

    Medical University of South Carolina Health • Charleston, SC, US
    [job_card.full_time]
    Join a team thats Changing Whats Possible.The Division of Endocrinology, Diabetes and Metabolic Diseases at the Medical University of South Carolina (MUSC) is seeking a candidate that is board cert...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Physician (MD / DO) - Cardiology - General / Other - $500,000 per year in Sumter, SC

    Physician (MD / DO) - Cardiology - General / Other - $500,000 per year in Sumter, SC

    LocumJobsOnline • North Charleston, South Carolina, US
    [job_card.full_time]
    Doctor of Medicine | Cardiology - General / Other.LocumJobsOnline is working with Curative to find a qualified Cardiology MD in Sumter, South Carolina, 29150!. General Cardiology in Sumter, South Caro...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Locum Physician (MD / DO) - Pathology in South Carolina

    Locum Physician (MD / DO) - Pathology in South Carolina

    LocumJobsOnline • North Charleston, South Carolina, US
    [job_card.full_time] +1
    Doctor of Medicine | Pathology.Competitive weekly pay (inquire for details) .LocumJobsOnline is working with Lancesoft Inc to find a qualified Pathology MD in South Carolina!.South Carolina (multip...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Principal Software Developer / Engineer

    Principal Software Developer / Engineer

    Naval Nuclear Laboratory • Charleston, South Carolina, US
    [job_card.full_time]
    Working at the Naval Nuclear Laboratory we foster pride in belonging to an organization whose culture is made up of these core values : Trust, Empowerment, and Collaboration.Our company promotes a p...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Locum Physician (MD / DO) in West Columbia, SC

    Locum Physician (MD / DO) in West Columbia, SC

    LocumJobsOnline • North Charleston, South Carolina, US
    [job_card.full_time] +1
    All Star Healthcare Solutions .Competitive weekly pay (inquire for details) .LocumJobsOnline is working with All Star Healthcare Solutions to find a qualified Other MD in West Columbia, South Carol...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel EP Tech / EP Lab Tech - $2,164 to $2,419 per week in Charleston, SC

    Travel EP Tech / EP Lab Tech - $2,164 to $2,419 per week in Charleston, SC

    AlliedTravelCareers • North Charleston, South Carolina, US
    [job_card.full_time]
    AlliedTravelCareers is working with Prime Time Healthcare to find a qualified Electrophysiology Tech in Charleston, South Carolina, 29401!. Now Hiring : Allied Healthcare EP - Charleston, SC.Contact ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Remote Investment Analyst – AI Trainer ($50-$60 / hour)

    Remote Investment Analyst – AI Trainer ($50-$60 / hour)

    Data Annotation • North Charleston, South Carolina
    [filters.remote]
    [job_card.full_time] +1
    We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Physician (MD / DO) - Endocrinology in West Columbia, SC

    Physician (MD / DO) - Endocrinology in West Columbia, SC

    LocumJobsOnline • North Charleston, South Carolina, US
    [job_card.full_time] +1
    Doctor of Medicine | Endocrinology.Competitive weekly pay (inquire for details) .LocumJobsOnline is working with CompHealth to find a qualified Endocrinology MD in West Columbia, South Carolina, 29...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Radiology Tech - $1,728 per week in Charleston, SC

    Travel Radiology Tech - $1,728 per week in Charleston, SC

    AlliedTravelCareers • North Charleston, South Carolina, US
    [job_card.full_time]
    AlliedTravelCareers is working with Medical Solutions to find a qualified Rad Tech in Charleston, South Carolina, 29425!. A facility in Charleston, SC is seeking its next amazing Rad Tech.Read on if...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Benign (Classical) Hematology Position in Charleston, SC

    Benign (Classical) Hematology Position in Charleston, SC

    Medical University of South Carolina Health • Charleston, SC, US
    [job_card.full_time]
    The Division of Hematology & Oncology at the Medical University of South Carolina.Preference for a qualified candidate suited to join the department as an Assistant, Associate Professor or Professo...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Statistical Programmer - Remote (US)

    Senior Statistical Programmer - Remote (US)

    MMS • Charleston, SC, US
    [filters.remote]
    [job_card.full_time]
    [filters_job_card.quick_apply]
    About MMS Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical...[show_more]
    [last_updated.last_updated_30]
    Travel Radiology Tech - $2,623 per week in Columbia, SC

    Travel Radiology Tech - $2,623 per week in Columbia, SC

    AlliedTravelCareers • North Charleston, South Carolina, US
    [job_card.full_time]
    AlliedTravelCareers is working with Mindlance Health to find a qualified Rad Tech in Columbia, South Carolina, 29203!.ID : 75041070 Shift : Day 5x8-Hour (07 : 00 - 15 : 30) Description : 40 hrs a week PLU...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Endoscopy RN PRN

    Endoscopy RN PRN

    HCA Healthcare Trident Hospital • North Charleston, South Carolina, US
    [job_card.full_time]
    Do you have the PRN career opportunities as a(an) Endoscopy RN PRN you want with your current employer? We have an exciting opportunity for you to join HCA Healthcare Trident Hospital which is part...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]