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Principal Statistical Programmer
2 weeks ago
Connect Life Sciences Bridgewater, United StatesActs as the lead programmer or project lead on studies of significant complexity, working directly with project team leaders and client representatives to conduct team meetings, develop and maintain project timelines, assess and forecast resources, and monitor study budgets. · As ...
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Biostatistician, Statistical Programmer
1 week ago
TechData Service Company LLC Bridgewater, United StatesJob Description · Job DescriptionResponsibilities · At project level, ensures the study designs are scientifically sound, the efficacy and safety endpoints meets regulatory requirements. · Provide statistical support to Clinical Development Plan for multiple compounds · Participa ...
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Principal Statistical Programmer
5 days ago
EPM Scientific Massachusetts, United StatesMy client a Biotech, is looking to hire a Principal Statistical Programmer to join their team How is this role unique? · Join the frontier of biomedical innovation with a cutting-edge clinical-stage biopharmaceutical powerhouse in their relentless pursuit of groundbreaking advanc ...
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Senior Statistical Programmer
2 weeks ago
Sarepta Therapeutics Cambridge, United StatesServes as a stat programming expert or point of contact for assigned clinical studies under close/limited supervision of the stat programming project lead · Primary Responsibilities Include: · • Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and ...
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Principal Statistical Programmer
5 days ago
Beacon Therapeutics (USA) Inc Cambridge, United StatesJob Description · Job DescriptionExciting opportunity for an experienced Clinical Statistical Programmer to join our team at Beacon Therapeutics (USA) Inc. as a Full Time Principal Statistical Programmer. In this fully remote position, you will have the chance to showcase your ex ...
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Manager, Statistical Programmer
1 hour ago
Takeda Development Center Americas, Inc San Francisco, United States PermanentTakeda Development Center Americas, Inc. is seeking a Manager, Statistical · Programmer in Lexington, MA to Lead study level programming and oversight activities ensuring quality and timelines; lead multiple studies, activities and parts of projects including studies or explorat ...
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Senior Statistical Programmer
2 weeks ago
Prometrika Cambridge, United StatesPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our compassion for the peop ...
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Senior Statistical Programmer
2 weeks ago
Cytel - USA & APAC Waltham, United StatesSr. Statistical Programmer (FSP) · Join Cytel's enthusiastic and collaborative Biometrics team by contributing to the overall success of our novel gene therapy development programs. The Sr. Statistical Programmer provides Statistical Programming technical support to team members ...
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Manager, Statistical Programmer
1 week ago
Takeda Development Center Americas, Inc Lexington, United StatesTakeda Development Center Americas, Inc. is seeking a Manager, Statistical · Programmer in Lexington, MA to Lead study level programming and oversight activities ensuring quality and timelines; lead multiple studies, activities and parts of projects including studies or explorat ...
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Manager, Statistical Programmer
3 weeks ago
Takeda Lexington, MA, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Noticeand Terms of Use. I further attest that all information I submi ...
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Principal Statistical Programmer
3 weeks ago
Katalyst Healthcares and Life Sciences Hanscom Air Force Base, United StatesResponsibilities: 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 out ...
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Principal Statistical Programmer
2 weeks ago
Prometrika LLC Cambridge, United StatesJob Description · Job DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our wor ...
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Principal Statistical Programmer
1 week ago
Prometrika Boston, MA, United StatesPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our compassion for the peop ...
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Senior Statistical Programmer
1 week ago
Prometrika LLC Cambridge, United StatesJob Description · Job DescriptionPROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our wor ...
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Senior Statistical Programmer
2 weeks ago
Galderma Boston, United States Full timeWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans th ...
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Remote Principal Statistical Programmer
3 weeks ago
Global Channel Management Framingham, United StatesJob Description: · Remote Principal Statistical Programmer needs 10 years Pharmaceutical/Biotech programming experience including macro/tools development experience. · Remote Principal Statistical Programmer requires: · Minimum 10 years Pharmaceutical/Biotech programming experie ...
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Statistical Programmer/Data Analyst RECOVER
1 week ago
Mass General Brigham Boston, United States RegularStatistical Programmer/Data Analyst RECOVER Description Massachusetts General Hospital (MGH) Biostatistics is seeking a Statistical Programmers/Data Analysts to join our team working on the National Institutes of Health (NIH) sponsored project, an initiative to understand, prev ...
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AbbVie Boston, United States**Company Description** · The Manager of Statistical Programming is a strategic role which guides a team of Statistical Programmers in the research and development of new pharmaceutical products. This role is directly responsible for leading the statistical programming activities ...
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Manager, Safety Statistical Programming
1 week ago
AbbVie Boston, United States**Company Description** · The Manager of Safety Statistical Programming is a strategic role in the emerging field of safety science providing programming expertise for development of pooled safety data sets and providing technical guidance to team of Statistical Programmers in th ...
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Clinical SAS Programmer
2 weeks ago
Katalyst Healthcares & Life Sciences Cambridge, United States**Responsibilities**: · - The SAS Programmer is responsible for developing and executing biostatistical (SAS) and data management related programs, processing data from various sources to support clinical and pharmaceutical projects and will include defining populations, creating ...
Principal Statistical Programmer - Bridgewater, United States - Katalyst HealthCares & Life Sciences
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 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.
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.
