- Serves as the primary project team representative, delegating work as appropriate.
- Generates SDTM domains, ADaM data sets, and files with proficiency in creating specification files for these domains.
- Generates analysis data sets, tables, figures, and listings to support the analysis of clinical trials data.
- Reviews output across programs to ensure consistency.
- Reviews maintains and approves study documents per standard procedures.
- Provides programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
- Programs, tests, and documents global utility programs and tools in accordance with standards and validation procedures
- Provides technical expertise in the development of programming standards and procedures, technical expertise in the areas of analysis and reporting.
- Participates in the development and/or maintenance of departmental procedures and standards.
- BS/BA degree in computer science, mathematics, statistics, or related discipline and 4+ years' experience in the Biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph). In addition, must have at least three years of experience serving in a supervisory or lead capacity. Experience managing projects OR
- Master's degree in computer science, mathematics, statistics, or related discipline and 1+ years of similar experience noted above OR
- PhD in computer science, mathematics, statistics, or related discipline and 2+ years of similar experience noted above.
- Demonstrates strong knowledge of industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
- Strong programming skills in SAS, (Base, Stat, Macro, graph), R, STAT or similar.
- Strong knowledge of SDTM domains, ADaM data sets, and files with proficiency in creating specification files for these domains.
- Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas.
- Proficient with tools and processes that support work conducted by functional area.
- bility to work as part of a team; may train lower levels.
- Excellent computer skills.
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Statistical programmer
2 weeks ago
Katalyst Healthcares and Life Sciences New York, United StatesResponsibilities:A statistical programmer consultant provides timely support to the study team on all programming matters according to the project strategies. · Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal ...
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Statistical programmer
1 week ago
Katalyst HealthCares & Life Sciences New York, United StatesResponsibilities: A statistical programmer consultant provides timely support to the study team on all programming matters according to the project strategies. · Requirements will be identified according to a Statistical Analysis Plan and programming specifications using interna ...
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Statistical Programmer
2 weeks ago
Source One Technical Solutions Parsippany, United StatesSource One is a consulting services company and we're currently looking for the following individual to work as a consultant to our direct client, a global pharmaceutical company in Parsippany, NJ. · Job Title: Statistical Programmer (Contractor) · Initial Duration: One year wit ...
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Statistical Programmer
1 week ago
Source One Technical Solutions Parsippany, United StatesSource One is a consulting services company and we're currently looking for the following individual to work as a consultant to our direct client, a global pharmaceutical company in Parsippany, NJ. · Job Title: Statistical Programmer (Contractor) · Initial Duration: One year with ...
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Statistical Programmer
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ShiftCode Analytics Parsippany, United StatesSTATISTICAL PROGRAMMER · 6+ MONTHS CONTRACT · PARSIPPANY, NEW JERSEY · HYBRID (2-3 DAYS/WEEK) · VISA- NO CPT/H1B · Manager-Statistical Programming, a hands-on with expert-level programmer in SAS and SQL, will lead in programming, managing and analyzing commercial administrati ...
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Statistical Programmer
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The Execu|Search Group Tarrytown, United StatesA recognized company in the Life Sciences industry is currently seeking a new Statistical Programmer to join their team in a Remote capacity. In this role, the Statistical Programmer will be responsible for providing timely support to the study team on all programming matters acc ...
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Statistical Programmer
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Katalyst Healthcares and Life Sciences Rahway, United StatesResponsibilities: Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies. · Provide statistical oversight to studies and assure adequate quality and consistency with project requireme ...
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Senior Statistical Programmer
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Principal Statistical Programmer
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IQVIA New York, United StatesLocation: Homebased anywhere in the US Purpose:Experienced R programmers needed to provide technical expertise to develop process methodology for department to meet internal and external clients needs. Plan and coordinate the development of integrated programming solutions servin ...
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Senior Statistical Programmer
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Manager, Statistical Programmer
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Takeda Pharmaceutical new york city, 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'sPrivacy Notice and Terms of Use. I further attest that all information I submi ...
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Sr. Statistical Programmer
2 weeks ago
Yoh, A Day & Zimmermann Company Parsippany, United StatesYoh has an exciting, opportunity for a Sr. Statistical Programmer to join our rapidly growing life science manufacturing client based in Parsippany, NJ. · The Senior Statistical Programmer, an adept programmer proficient in SAS and SQL, will oversee programming, management, and a ...
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Senior Statistical Programmer
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EG Life Sciences (now Eliassen Group) New Jersey, United StatesNO THIRD PARTY CANDIDATES · Eliassen is looking to add to our PK/PD FSP team, servicing a large Pharmaceutical client. · Detailed Job overview/ requirements · Ability to contribute to and lead standardization of processes for PKPD group including dataset creation, QC process, re ...
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Sr. Statistical Programmer
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Yoh Parsippany Troy Hills, NJ, United StatesYoh has an exciting, opportunity for a Sr. Statistical Programmer to join our rapidly growing life science manufacturing client based in Parsippany, NJ. · The Senior Statistical Programmer, an adept programmer proficient in SAS and SQL, will oversee programming, management, ...
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Senior Statistical Programmer
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Principal Statistical Programmer
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Regeneron Pharmaceuticals, Inc. Basking Ridge, United States Full timeThe Principal Statistical Programmer will lead and support all programming activities per the project strategies and should be able to work independently implementing and driving the programming to support ongoing clinical studies and requests for study report, regulatory submiss ...
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Principal Statistical Programmer
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Sr. Manager, Statistical Programmer
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Yoh Parsippany Troy Hills, NJ, United StatesYoh has an exciting, opportunity for a Sr. Manager, Statistical Programming to join our rapidly growing life science manufacturing client based in Parsippany, NJ. · The Senior ManagerStatistical Programming, an adept programmer proficient in SAS and SQL, will oversee programm ...
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Principal Scientist- Statistical Programmer
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TechData Service Company LLC Basking Ridge, United StatesJob Description · Job DescriptionSr. Biostatistician · Responsibilities · 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 ...
Statistical Programmer - Nutley, United States - Katalyst Healthcares and Life Sciences
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