Talent.com
Katalyst HealthCares & Life Sciences
Principal Statistical ProgrammerKatalyst HealthCares & Life Sciences • San Francisco, CA
Principal Statistical Programmer

Principal Statistical Programmer

Katalyst HealthCares & Life Sciences • San Francisco, CA
30+ days ago
Job type
  • Full-time
Job description

Responsibilities:
  • Participate in developing and maintaining clinical trial data and statistical programming standards to ensure the company standards are up to date and in line with pharmaceutical industry standards, conventions, and regulatory requirements.
  • Perform hands on primary statistical programming and validation programming on assigned projects including but not limited to phase I – IV clinical trials, integrated clinical summaries, responses to requests from regulatory agencies, publication support, data explorations, data monitoring committee meetings, etc.
  • Create SDTM mapping specifications and ADaM data specifications.
  • Perform quality control (QC) review of these documents prepared by others.
  • Create SDTM and ADaM files.
  • Perform QC review of these files prepared by others.
  • Perform rd level QC review on programming deliverables before their release to the clients.
  • Perform QC review/assessment on regulatory submission programming documents, datasets, tables/listings/graphs (TLGs), and computer programs, etc.
  • May lead programming efforts for drug development programs or for assigned client clusters.
  • Provide training, mentorship, and technical guidance to less experienced Statistical Programmers or Biostatisticians who perform statistical programming.
  • SOPs, guidelines, and good working practices.
  • Participate in statistical programming project bidding or bid defense meetings.
  • Work with document management specialists/archivists to plan and perform archival of the statistical programming datasets, outputs, documents, and final programs upon the completion of the assigned projects.
  • Perform transfer of the archived files to the clinical trial sponsors.

Requirements:
  • , or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
  • An in-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies.
  • Knowledge of industry standards on how clinical trial data are structured, stored, analyzed, and presented. Knowledge of clinical trial regulatory and ICH requirements.
  • Must demonstrate ability to effectively plan, control, and carry on tasks in SAS programming, statistical analysis, and submission of trial data and results to regulatory agencies.
  • Must possess in-depth level understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations.
  • Must have sound technical judgment and experience in process design and implementation in relevant areas.
  • Strong leadership and drive to achieve goals will be required.

Create a job alert for this search

Principal Statistical Programmer • San Francisco, CA

Similar jobs

Oncology Principal Investigator

Plexus PartnersOakland, CA, United States
Full-time

Oncologist / Principal Investigator - Clinical Research leadership.Los Angeles, CA (relocation assistance provided).We are representing an exceptional.The position is ideal for an oncologist who wa... Show more

 • Promoted

Principal Scientist

OneDigital NorCal HR ConsultingSan Carlos, CA, United States
Full-time

OneDigital NorCal HR Consulting provided pay range.This range is provided by OneDigital NorCal HR Consulting.Your actual pay will be based on your skills and experience — talk with your recruiter t... Show more

 • Promoted

Pathologist

Kaiser Permanente - The Permanente Medical Group, Inc. -Northern CaliforniaRedwood City, US
Full-time

BE/BC Pathologist to join our team in Redwood City, CA.The Permanente Medical Group, Inc.Northern and Central California and an 80-year tradition of providing quality medical care.Board Certificati... Show more

 • Promoted

Pathologist in Redwood City

The Permanente Medical Group, Inc. - N.CaliforniaRedwood City, CA, US
Full-time

Pathologist Opportunity in Redwood City, CA with Kaiser Permanente.Leading the future of health care.Kaiser Permanente / The Permanente Medical Group.BE/BC Pathologist to join our team in Redwood C... Show more

 • Promoted

Senior / Principal Research Associate, Cancer Biology

Yoh, A Day & Zimmermann CompanySouth San Francisco, CA, United States
Full-time

Senior / Principal Research Associate, Cancer Biology.Senior / Principal Research Associate, Cancer Biology.Be among the first 25 applicants.Get AI-powered advice on this job and more exclusive fea... Show more

 • Promoted

Travel Interventional Radiology (IR) - $2,845 per week in Redwood City, CA

AlliedTravelCareersRedwood City, CA, US
Full-time

Atlas Medstaff is currently seeking candidates in the SP/IR Tech (SP/IR Tech) profession for a 13 week contract in the Redwood City, California area.Atlas Medstaff is a premier staffing firm dedica... Show more

 • Promoted

Bioinformatics Programmer

LumicitySan Francisco, CA, United States
Full-time

Direct message the job poster from Lumicity.Contract Recruitment Consultant at Lumicity | Medical Affairs, Bio Statistics, Medical Writing, Clinical Operations, Clinical Research, and Clinical….Dur... Show more

 • Promoted

Principal Engineer - AI Tools

UberSan Francisco, CA, United States
Full-time

At Uber, developer productivity is a cornerstone of our innovation engine.We are seeking a world‑class Principal Engineer (Director‑equivalent) to lead the next frontier of software development by ... Show more

 • Promoted

Principal Engineer, Generative AI- Hybrid(SF) preferred, remote OK

Unit21, Inc.San Francisco, CA, United States
Remote
Full-time

Principal Engineer, Generative AI- Hybrid(SF) preferred, remote OKSan Francisco, United States Posted on 09 / 23 / 2025At Unit21, we believe that combating financial crime demands a united front.Th... Show more

 • Promoted

AI Programmer

Syntes, Inc.San Francisco, CA, United States
Full-time

San Francisco, CA, US or Remote New York City, NY, US or Remote.Syntes AI software platform—a cloud-based solution for Multi-Domain Data Management and Data Analytics using Artificial Intelligence ... Show more

 • Promoted

Senior · Staff · Principal Machine Learning Engineer

Lead Allies IncSan Francisco, CA, United States
Full-time

Senior / Staff / Principal Machine Learning Engineer.Location: Onsite San Francisco (5 days onsite AND hybrid options).We have multiple startups interested in talent.Instead of a perfect job descri... Show more

 • Promoted

Senior / Principal Software Engineer (Compiler & AI Tooling)

Code MetalSan Francisco, CA, US
Full-time
Quick Apply

Code Metal is redefining code translation for mission-critical industries, helping partners move more quickly and reliably from algorithm to silicon.Our platform accelerates deployment of DSP, RF, ... Show more

Principal Data Platform Architect – DaaS & Scale

WEX, Inc.San Francisco, CA, United States
Full-time

A leading technology firm in San Francisco is seeking a Principal Staff Software Engineer to architect its Data-as-a-Service platform.The role requires extensive experience in software engineering,... Show more

 • Promoted

Sr Principal Data Engineer

AutodeskSan Francisco, CA, United States
Full-time

Senior Principal Data Engineer.At Autodesk, we as Enterprise Data Engineering team are pivotal in driving business growth and improving operational efficiency through innovative data solutions and ... Show more

 • Promoted

Physician, Neuropalliative (Berkeley/Castro Valley, CA)

Sutter HealthBerkeley, CA, US
Full-time

Neurologist, Neuro-Palliative Berkeley, Castro Valley, CA.Sutter East Bay Medical Group (SEBMG).Neurologist to join a collaborative group of clinicians who practice evidence-based medicine in a tea... Show more

 • Promoted

Principal Scientist, Cancer Biology

General ProximitySan Francisco, CA, United States
Full-time

We are seeking an experienced cancer biologist to help lead our Biology Team.In this position, you will help lead and manage our Biology Team and work closely with our Platform Team in the developm... Show more

 • Promoted

Remote-First Strategic Principal Data Scientist

AtlassianSan Francisco, CA, United States
Remote
Full-time

A technology company in San Francisco seeks an experienced Principal Data Scientist to collaborate with cross-functional partners and apply data-driven strategies to solve complex business challeng... Show more

 • Promoted

Manager, Statistical Programming (Remote)

AbbVieSouth San Francisco, CA, United States
Remote
Full-time

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.We strive to ... Show more