Talent.com
Principal Statistical Programmer
Principal Statistical ProgrammerKatalyst HealthCares & Life Sciences • Durham, NC
Principal Statistical Programmer

Principal Statistical Programmer

Katalyst HealthCares & Life Sciences • Durham, NC
30+ days ago
Job type
  • Full-time
Job description

Responsibilities:
  • Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.
  • Be responsible for overall project delivery, including clinical trial reports and other regulatory submission deliverables.
  • Create statistical analysis outputs to be used in support of final reports, abstracts, posters, Manu scripts, and other clinical publications; support systems to produce electronic regulatory submissions.
  • Assist in establishing standardized programming procedures and work instructions.
  • Develop, enhance, evaluate, and validate standardized macros and utility programs to ensure that regulatory requirements are met through validation/compliance activities.
  • Develop and maintain clinical processing workflow systems.
  • Assist in the development of client proposal documents.
  • Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.
  • Provide input into and negotiate statistical programming timelines. Ensure that timelines are adhered to and coordinate and lead a statistical programming team to successful completion of a study within given timelines and budgets.
  • Trained in sponsor SOPs and disseminate knowledge to project team members as appropriate.
  • Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (, biostatisticians, data managers, medical writers, etc.) records handling (, Chapter of the US Code of Federal Regulation – Part ), and electronic submission of clinical data to agencies (, e-CTD guidance and CDISC SDTM and ADaM standards).
  • Assist in updating/writing PROMETRIKA standard operating procedures (SOPs).
  • Develop tools in SAS for data analysis and reporting that comply with regulatory requirements.
  • Develop specifications (, metadata files), annotate CRFs and create SAS programs for the mapping of raw datasets to CDISC SDTM standards.
  • Create files from metadata files for SDTM and ADaM.
  • Convert data received in other formats to SAS datasets.
Requirements:
  • Must have expertise in SAS/BASE, SAS/STAT, and knowledge of SAS/CONNECT, SAS/ACCESS, SAS/MACRO, SAS/GRAPH, SQL, and ODS.
  • Knowledge of SDTM, ADaM, FDA and ICH guidance.
  • Understanding of Code of Federal Regulations (CFR) Title , Part that covers the management of electronic records and electronic signatures in computer systems.
  • Good organizational skills across individual projects and managing own and teamwork loads. Ability to organize, manage and complete multiple assignments with challenging timelines independently and effectively.
  • Consistent experience as a lead statistical programmer on several concurrent projects.
  • Strong understanding of drug development, including knowledge of interfaces and interdependencies with other functions.
  • Strong mentoring skills as shown by leadership of projects and if applicable, junior team members.
  • Excellent analytical skills.
  • Proven ability to learn new systems and function in an evolving technical environment.
  • Ability to negotiate and influence to achieve results.
  • Good presentation skills.
  • Good business awareness/business development skills (including financial awareness).
  • Ability to create, maintain and define strategies to improve the efficiency of running a clinical trial.
  • Work effectively in a quality-focused environment.
  • Knowledge of other programming languages and database management software packages is a plus.

Create a job alert for this search

Principal Statistical Programmer • Durham, NC

Similar jobs

Insights and Analytics Principal, Large Pharma

GenaeDurham, NC, United States
Full-time

Insights And Analytics Principal, Large Pharma.Durham, United States Of America | Full Time | Hybrid.The Insights And Analytics Principal is a senior analytics leader responsible for driving busine...Show more

 • Promoted

Remote Data Visualization Programmer (SAS, R / Shiny)

NCBiotechDurham, NC, United States
Remote
Full-time

A global clinical research services provider is seeking a Statistical Programmer to work within a prominent Pharma company's data visualization team.Responsibilities include programming visualizati...Show more

 • Promoted

Principal Software Architect

Toshiba Global Commerce Solutions - ExternalDurham, NC, United States
Full-time

Toshiba Global Commerce Solutions is seeking a hands‑on Principal Software Architect to lead end‑to‑end solution delivery for major retail platforms.In this role, you will own architecture leadersh...Show more

 • Promoted

Manager, Statistical Modeling (JMP) remote / hybrid

SASDurham, NC, United States
Remote
Full-time

Manager, Statistical Modeling (JMP) remote / hybridRequisition ID 20066952 Primary Location - Country United States Visa Sponsorship No Travel Requirements NoneJMP, a subsidiary of SAS, is committe...Show more

 • Promoted

Translational Research Scientist - DPMP

InsideHigherEdChapel Hill, North Carolina, United States
Full-time +1

Translational Research Scientist - DPMP.Estimated Duration of Appointment:.A global higher education leader in innovative teaching, research and public service, the.University of North Carolina at ...Show more

 • Promoted

Hematology/Oncology Physician

Novant HealthNot Specified, NC, United States
Full-time

Novant Health Cancer Institute-Mount Airy is seeking a medical oncologist.Well-established practice located in Mount Airy NC, near Winston-Salem.The Triad Region is a division of Novant Health Canc...Show more

 • Promoted

Metrologist

MedPharmDurham, NC, US
Full-time
Quick Apply

This position contributes to the company success by providing calibration and instrumentation oversight for lab equipment through executing scheduled calibrations and preventative / corrective main...Show more

Women Under 40: Earn $35,000–$40,000 as a Surrogate

Prime GeneticsTimberlake, None, US
Full-time

Do you want to become a surrogate? .We are now offering a sign on bonus to all qualified and matched surrogates that sign contracts.The first step is to fill out our surrogate application.A fertili...Show more

 • Promoted

Remote Macroeconomic Modeling Specialist (EViews)

Micro1Roxboro, North Carolina, US
Remote
Full-time

Macroeconomic Modeling Specialist (EViews).AI labs train foundational models and enterprises build AI agents.We provide frontier evaluations and reinforcement learning environments used to improve ...Show more

 • Promoted

Hepatitis Epidemiologist: Surveillance & Data Insight

Arts In WilmingtonDurham, North Carolina, United States
Full-time

A state public health organization is seeking a qualified candidate in North Carolina to conduct surveillance data review and analyses for hepatitis B and C.Responsibilities include producing epide...Show more

 • Promoted

Freelance Machine Learning Engineer

MindriftNC, US
Remote
Part-time +1
Quick Apply

Please submit your CV in English and indicate your level of English proficiency.Mindrift connects specialists with project-based AI opportunities for leading tech companies, focused on testing, eva...Show more

Assistant Principal of Academics Multiple Openings

Triad Math and Science Academy Co. dba The Math & Science Academy of ApexApex, NC, US
Full-time

Assistant Principal of Academics (Multiple Openings) - Ensures alignment betw school curr & state’s accountability prog; Impl MTSS process & proced; etc.Bachelor’s in Education, Curriculum & Instru...Show more

 • Promoted

Epic Principal Trainer

Intellibee Inc.NC, US
Full-time

Clinical Documentation Principal Trainer (Epic) Clinical Documentation Principal Trainer responsible for developing and delivering EHR training, supporting providers, and optimizing documentation w...Show more

 • Promoted

Principal Clinical Data Scientist- Data Managment

Syneos Health, Inc.NC, United States
Full-time

Principal Clinical Data Scientist- Data Management.Principal Clinical Data Scientist- Data Management.Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to ...Show more

 • Promoted

Principal Appian Consultant

GroundswellNC, United States
Full-time

Groundswell is a premier technology integrator and solution provider, resolutely committed to solving the most complex challenges facing federal agencies today.Our name, Groundswell, represents our...Show more

 • Promoted

AI/ML (14 years) USC and GC

Hudson ManpowerDurham, NC, US
Full-time

The ideal candidate will be passionate about artificial intelligence, natural language processing, and large language models (LLMs), with the ability to design, develop, and deploy GenAI-driven sol...Show more

Hematologist/Oncologists Needed for Locum Tenens Coverage at Clinic in Asheville, North Carolina

HealthEcareers - ClientNew Hill, NC, USA
Full-time

Job Reference Id: ORD-208279-MD-NC.Board Certification Required: Yes.The facility operates as a dedicated outpatient cancer center providing comprehensive oncology services.The center maintains mod...Show more

 • Promoted

Surrogates Start at $55K–$75K+ | $1,200 Bonus + $11K Pre-Pregnancy Payout

Physician's SurrogacyRoxboro, NC, US
Full-time +2

Surrogates Start at $60K$75K+ $1,250 Bonus + $11K Pre-Pregnancy Payout.Looking for a high-paying opportunity with real support and no upfront costs?.Become a Surrogate and earn up to.All expenses p...Show more