Principal Statistical Programmer
Katalyst Healthcares and Life Sciences
Responsibilities:
Requirements:
- 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 define.xml files.
- Perform QC review of these files prepared by others.
- Perform 3rd 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:
- M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
- n 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.
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Principal Statistical Programmer in San Francisco, CA vacancy
$250k - $295k
...Senior Principal Programmer San Francisco, CA or Remote or Hybrid Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering... ...skills: At least 10 years of experience in clinical statistical programming in biotechnology/pharmaceutical industry...SuggestedInterim roleRemote workFlexible hoursBraveheart Bio
San Francisco, CA1 day ago- ...processes and identify opportunities for continuous improvement and automation to enhance efficiency and effectiveness. Utilize data and statistical techniques to collect, analyze, and interpret data to provide insights and recommendations to senior management....SuggestedFull time
Maxonic
San Francisco, CA5 days ago $220k - $250k
...inequalities for many communities, especially in the tech industry. We recognize that women and underrepresented minorities are statistically less likely to apply for a role that they feel unqualified for. If you are interested in this role but you're concerned about not...SuggestedWork at officeRelocationRelocation packageGraphite
San Francisco, CA4 days ago$195k
...and R&D teams to correlate characterization data with process variation, yield trends, and overall device performance Implement statistical process control (SPC) methodologies and data analysis techniques to support process monitoring and continuous improvement...SuggestedFlexible hoursGyga Force
San Francisco, CA2 days ago$220k - $280k
...verbal communication; comfortable working across product, research, and engineering A research background in machine learning, statistics, or a related field (MS, PhD, or equivalent research experience) is a plus but not a requirement Not sure if you meet 100% of the...SuggestedHourly payShift work$140k - $195k
...our single crystal diamond technology. We are seeking a Snr. Principal Metrology Engineer to lead metrology initiatives, develop advanced... ..., polishing, thinning, cleaning, and bonding), implement statistical process control (SPC), and ensure compliance with industry standards...Local areaFlexible hours$288.59k - $384.79k
...advertisements around the world. Job Summary We are seeking a Sr Principal Scientist of Research & Optimization Sciences to lead a world-... ..., Computer Science, Operations Research, Applied Mathematics, Statistics, Economics, or related quantitative field. ~15+ years of...Work experience placementLocal areaNight shiftWeekend workComcast
San Francisco, CA3 days ago$170.26k - $200.3k
...Extensive knowledge of various regression techniques, parametric and non-parametric algorithms, times series techniques, and other statistical models, various model validation tests/methodologies, using SAS or similar statistical packages. Advanced data compilation,...Temporary workLocal area3 days per weekU.S. Bank
San Francisco, CA5 days ago$240k - $300k
Why join us Brex is the intelligent finance platform that enables companies to spend smarter and move faster in more than 200 markets. By combining global corporate cards and banking with intuitive spend management, bill pay, and travel software, Brex enables founders...Work at officeRemote workWork from homeBrex
San Francisco, CA1 day ago- Director Of Engineering The Director of Engineering is responsible for planning and managing the shared services, managing the team of engineers and reporting to the Vice President, Engineering. The right candidate is comfortable working with a wide range of technologies...
Black Swan Search
San Francisco, CA4 days ago - About Airwallex Airwallex is the only unified payments and financial platform for global businesses. Powered by our unique combination of proprietary infrastructure and software, we empower over 200,000 businesses worldwide - including Brex, Rippling, Navan, Qantas...WorldwideShift work
Airwallex
San Francisco, CA5 days ago $265k - $364.3k
GAQ125R25 As Head of Corporate Engineering, you will be responsible for Enterprise engineering and operations globally. You will be responsible for building and managing a highly technical enterprise engineering team, developing first principled-based strategies, and...Work experience placementRemote workWorldwideDatabricks
San Francisco, CA1 day ago- Who We Are Serval is an AI-native automation platform transforming how enterprises operate. We build intelligent agents that understand real-world workflows and execute them end-to-end — replacing manual processes and rigid legacy systems with adaptive, learning software...
Serval
San Francisco, CA1 day ago $190.9k - $253.75k
RDQ426R230 At Databricks, we are passionate about enabling data teams to solve the world's toughest problems - from making the next mode of transportation a reality to accelerating the development of medical breakthroughs. We do this by building and running the world...Local areaWorldwideDatabricks
San Francisco, CA2 days ago$50k
About Datawizz Datawizz is building the agent workforce. We're a seed-stage team backed by Human Capital (SpaceX, Snowflake, Anduril) building a platform that helps enterprises build and deploy agents - with the right permissions, guardrails, and activity logging ...Work at officeDatawizz
San Francisco, CA5 days ago$180k - $220k
About the Role A seed-stage neurotechnology startup in San Francisco is hiring a Head of Engineering - a founding leadership role for someone who can set technical direction and still ship code every day. You'll partner directly with the Founder to define product...Work at officeFlexible hoursClera
San Francisco, CA4 days ago$230k - $300k
Cardless Engineering Manager At Cardless, we're building a credit card and loyalty platform that consumer businesses use to engage their customers. We power programs for names like Coinbase, Bilt, Qatar Airways, and Alibaba — real products, real cardholders, real transaction...Work at officeRelocation packageFlexible hoursCardless
San Francisco, CA4 days ago- Connectivity Engineering Manager Anrok is the leading tax automation platform enabling businesses to expand globally without compliance complexity. As the digital economy has grown 6x over the last decade, software businesses have gone from not worrying about sales...Work at officeHome officeFlexible hours3 days per week
Anrok
San Francisco, CA3 days ago - Machine Learning Engineer Chalk is building the data platform that powers the future of machine learning applications. We tear down complexity, latency, and scale barriers that have traditionally constrained ML capabilities. Our platform combines Rust-speed performance...Work at officeFlexible hours
CHALK INC
San Francisco, CA4 days ago - Head Of Outcome Engineer Every production AI system, whether it's powering customer support, writing code, analyzing financial data, or diagnosing medical conditions, needs the same foundational infrastructure. A way to route between models. A way to manage tools and...
TrueFoundry
San Francisco, CA4 days ago - About Opal Security: At Opal, we're building modern identity governance for the AI era-intelligent access management that empowers enterprises to move fast while staying secure. Our mission is to bring clarity, control, and confidence to complex enterprise environments...Temporary work
Opal Services
San Francisco, CA5 days ago $280k - $350k
Healthcare is broken at the first step: patients can't find the right care, understand what it costs, or access the medications they need. Mochi Health is fixing this. We're building an AI-driven marketplace that makes healthcare discoverable-connecting patients to ...Full timeCasual workWork at officeLocal areaRemote workMochi Health
San Francisco, CA4 days ago$225k - $295k
About Unify Unify is building the first AI-powered system of action for revenue teams , helping companies transform outbound into a top-performing growth engine by making go-to-market execution observable, repeatable, and scalable. Founded in 2023 by leaders from...Unify
San Francisco, CA5 days ago- About Airwallex Airwallex is the only unified payments and financial platform for global businesses. Powered by our unique combination of proprietary infrastructure and software, we empower over 200,000 businesses worldwide - including Brex, Rippling, Navan, Qantas...Local areaWorldwide
Airwallex
San Francisco, CA3 days ago - Superpower is building the future of preventative health. We help people unlock peak performance and longevity-and we're working to put an AI doctor in every person's pocket. We have product-market fit, are growing fast, and are ~12 months from $100M revenue and a $...RelocationVisa sponsorship
Superpower Health, Inc
San Francisco, CA3 days ago $240k - $300k
Engineering Manager Opportunity At Mandolin Nearly every disease will become treatable in our lifetimes. Mandolin is laying the clinical and financial infrastructure to get groundbreaking treatments to patients faster, powered by AI agents. Mandolin partners closely...Full timeWork at officeLocal areaMandolin
San Francisco, CA1 day ago- About Collective: Collective is on a mission to redefine the way businesses-of-one work. Our technology and team of trusted advisors help members achieve financial independence by taking care of everything from business incorporation to accounting, bookkeeping, tax services...Self employmentWork at officeRemote workFlexible hours
Freelance Headhunters Collective
San Francisco, CA3 days ago $275k - $350k
About Us Beast Industries is a multifaceted media and entertainment company founded by Jimmy Donaldson, popularly known as MrBeast, the most watched person in the world. Renowned for revolutionizing digital content creation, Beast Industries encompasses a diverse ...Relocation packageFlexible hoursMrBeast
San Francisco, CA5 days ago$252k - $315k
At Scale AI, our mission is to accelerate the development of AI applications. For 8 years, Scale has been the leading AI data foundry, helping fuel the most exciting advancements in AI, including: generative AI, defense applications, and autonomous vehicles. With our recent...Full timeFlexible hoursScale AI
San Francisco, CA9 days ago- Engineering Manager Logistics is broken. Let's fix it. We are a team of engineers, product designers, and customer champions applying the most transformative technology of our times, AI, to one of the largest industries in the world: logistics. Our mission is to ...Work at officeLocal areaFlexible hours
Augment
San Francisco, CA4 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Principal Statistical Programmer. Be the first to apply!
Related searches
- principal battery engineer San Francisco, CA
- senior civil engineer project manager San Francisco, CA
- senior chief engineer San Francisco, CA
- principal reliability engineer San Francisco, CA
- director of product engineering San Francisco, CA
- engineering director San Francisco, CA
- chief engineer San Francisco, CA
- chief design engineer San Francisco, CA
- principal network engineer San Francisco, CA
- data center chief engineer San Francisco, CA