Statistical Programmer

hace 1 semana

Buenos Aires, Buenos Aires C.F., Argentina Indero A tiempo completo $30.000 - $60.000 al año

The Statistical Programmer will be responsible for the development, maintenance, and validation of aCRFs, as well as of specifications and statistical programming of SDTMs, ADaMs (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, IDMCs, IAs, and CSRs. The Statistical Programmer will also support DM with data cleaning activities, use global SAS macros, participate to internal initiatives to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs, and use Pinnacle 21 to validate SDTMs, ADaMs, and define.XMLs.

The Statistical Programmer will work collaboratively within Biostatistical study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable ICH guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Indero's SOPs and processes.

More specifically, the Statistical Programmer will:

  • Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time.
  • Review the statistical programming scope of work and budget at initiation of clinical trials and identify tasks that are out of scope.
  • Support DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician.
  • Develop/maintain/validate (as applicable) aCRFs according to protocol, eCRF, and Indero and/or Sponsor' standards and interpretation of CDISC SDTM IG and CT.
  • Develop/maintain/validate (as applicable) specifications and Primary or QC statistical programming (as applicable) of SDTMs, ADaMs (or derived datasets, as applicable), and TLFs.
  • Develop/maintain/validate (as applicable) SDTM define.XML/.PDF, cSDRG, ADaM define.XML/.PDF, and ADRG
  • Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21
  • Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs.
  • Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables and participate to the realization of these internal initiatives.
  • Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements.

May also:

  • Act as a Lead Statistical Programmer on single studies. 
  • Review and provide input into SAPs, TLF Shells, and various DM documents (e.g., eCRFs, edit checks, etc.)
  • Act as Unblinded Primary or QC Statistical Programmer for IDMCs and IAs.
  • Coach more junior Statistical Programmers.

Education

  • Bachelor' degree in Statistics, Computing Sciences or a related field; Master's degree an asset

Experience

  • At least 1 years of clinical research experience in biotechnology, pharmaceutical or CRO industry, including 1 years of Statistical Programming.

Knowledge and skills

  • Significant exposure to clinical trial data, SAP, TLF Shells, and specifications.
  • Excellent working knowledge of SAS; SAS certification an asset.
  • Knowledge of XML programming an asset.
  • Good working knowledge of CDISC standards and guideline; CDISC certification an asset.
  • Good knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant HC and FDA regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP.
  • Very organized and detail-oriented, with effective project planning and time management skills.
  • Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands.
  • Must be able to work independently and as part of a team.
  • Strong verbal and written communication skills in English

The work environment 

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

In this position, you will be eligible for the following perks: 

  • Flexible work schedule / work schedule :
  • Home-based position
  • Ongoing learning and development 

About Innovaderm  

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe. 

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. 

Innovaderm only accepts applicants who can legally work in Argentina

  • Statistical Programmer

    hace 1 semana

    Buenos Aires, Buenos Aires C.F., Argentina Indero A tiempo completo $120.000 - $240.000 al año

    The Statistical Programmer will be responsible for the development, maintenance, and validation of aCRFs, as well as of specifications and statistical programming of SDTMs, ADaMs (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, IDMCs, IAs, and...

  • Statistical Programmer

    hace 1 semana

    Buenos Aires, Buenos Aires C.F., Argentina Indero (formerly Innovaderm) A tiempo completo $900.000 - $1.200.000 al año

    The Statistical Programmer will be responsible for the development, maintenance, and validation of aCRFs, as well as of specifications and statistical programming of SDTMs, ADaMs (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, IDMCs, IAs, and...

  • Senior Statistical Programmer

    hace 1 semana

    Buenos Aires, Buenos Aires C.F., Argentina Indero A tiempo completo $1.500.000 - $3.000.000 al año

    PLEASE SUBMIT YOUR RESUME IN ENGLISHThe Senior Statistical Programmer will lead single and/or multiple clinical trials and be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM)...

  • Senior Statistical Programmer

    hace 1 semana

    Buenos Aires, Buenos Aires C.F., Argentina Indero (formerly Innovaderm) A tiempo completo $1.200.000 - $2.000.000 al año

    PLEASE SUBMIT YOUR RESUME IN ENGLISHThe Senior Statistical Programmer will lead single and/or multiple clinical trials and be responsible for the development, maintenance, and validation of annotated Case Report Forms (aCRFs) as well as of specifications and statistical programming of Standard Data Tabulation Model (SDTM) datasets, Analysis Data Model (ADaM)...

  • Senior or Principal Statistical Programmer

    hace 1 semana

    Buenos Aires, Buenos Aires C.F., Argentina Fortrea A tiempo completo $900.000 - $1.200.000 al año

    As a Senior or Principal Statistical Programmer in our sponsor-dedicated Flexible Solutions business unit, you will be central to the successful delivery of complex global oncology clinical trials (Phases I–III) for some of the world's most renowned and innovative pharmaceutical companies.In this role, you will contribute to the development of new and...

  • Statistical Programmer II

    hace 1 semana

    Buenos Aires, Buenos Aires C.F., Argentina Capgemini Engineering A tiempo completo $250.000 - $450.000 al año

    Since June 2021, frog is part of Capgemini Invent . frog partners with customer-centric enterprises to drive sustainable growth, by building and orchestrating experiences at scale, while harnessing the power of data and technology. We're inventing the future of customer experiences by delivering market-defining business models, products, services, brand...

  • Production Programmer

    hace 7 días

    Buenos Aires, Buenos Aires C.F., Argentina Prysmian Group A tiempo completo $40.000 - $80.000 al año

    Visión general del rol y responsabilidades La persona que ocupe la posición de Programador de Producción será responsable de la programación y control de las líneas de producción del sector de Energía. Deberá administrar y controlar las actividades desarrolladas en las diferentes fases de producción, organizando y orientando los servicios...

  • Production Programmer

    hace 7 días

    Buenos Aires, Buenos Aires C.F., Argentina Prysmian Group A tiempo completo $40.000 - $80.000 al año

    Visión general del rol y responsabilidadesLa persona que ocupe la posición de Programador de Producción será responsable de la programación y control de las líneas de producción del sector de Energía. Deberá administrar y controlar las actividades desarrolladas en las diferentes fases de producción, organizando y orientando los servicios realizados...

  • Data Analyst

    hace 16 horas

    Buenos Aires, Buenos Aires C.F., Argentina Rombit A tiempo completo

    As a Data Analyst, you will deliver data-driven insights and decisions, both as part of operational needs and product improvements. You will work closely with the operational and product teams to translate key business-questions into the appropriate plans for querying available data, collecting new data and inferring the desired information. Main...

  • LATAM Lead Statistical Programmer

    hace 2 días

    Buenos Aires, Argentina Syneos Health group A tiempo completo

    A leading biopharmaceutical solutions organization is seeking a Senior Statistical Programmer in LATAM. This role involves developing custom programming code for statistical analysis, ensuring high quality outputs, and leading programming activities across projects. Candidates should have a solid background in SAS programming and excellent communication...

  • Statistical Programmer Ii

    hace 3 días

    Buenos Aires, Argentina Capgemini Engineering A tiempo completo

    Since June 2021, **frog is part of Capgemini Invent**. frog partners with customer-centric enterprises to drive sustainable growth, by building and orchestrating experiences at scale, while harnessing the power of data and technology. We’re inventing the future of customer experiences by delivering market-defining business models, products, services, brand...

  • Senior Statistical Programmer

    hace 2 días

    Buenos Aires, Argentina Syneos Health group A tiempo completo

    Senior Statistical Programmer (LATAM Only) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...

  • Production Programmer

    hace 24 horas

    Buenos Aires, Argentina Prysmian Group A tiempo completo

    Visión general del rol y responsabilidades La persona que ocupe la posición de Programador de Producción será responsable de la programación y control de las líneas de producción del sector de Energía. Deberá administrar y controlar las actividades desarrolladas en las diferentes fases de producción, organizando y orientando los servicios...

  • Regulatory & Start Up Specialist, Fsp

    hace 4 días

    Buenos Aires, Argentina FullStack Labs A tiempo completo

    Regulatory & Start Up Specialist We are looking for a Regulatory & Start Up Specialist to join our FSP team in a Home Based role! What You'll Do Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and...

  • Statistical Programmer in Clinical Trials, Entry

    hace 3 días

    Buenos Aires, Argentina Labcorp A tiempo completo

    Are you ready to discover your extraordinary potential at Labcorp Drug Development? A career here provides the unique chance to create a lasting impact and difference in patients’ lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy, innovative & collaborative workplace, along with access to comprehensive...

  • Sas Programmer I

    hace 7 días

    Buenos Aires, Argentina PSI CRO A tiempo completo

    Company Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,200 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who...

  • Search form

    hace 6 días

    Buenos Aires, Argentina Syneos Health, Inc. A tiempo completo

    Statistical Programmer Pipeline for 2026 Statistical Programmer Pipeline for 2026 Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model...

  • Sas Programmer I

    hace 2 semanas

    Buenos Aires, Argentina PSI CRO A tiempo completo

    Company Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,200 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who...

  • Sas Programmer Ii

    hace 2 semanas

    Buenos Aires, Argentina PSI CRO A tiempo completo

    Company Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who...