Description
The 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) datasets (or derived datasets, as applicable), Tables, Listings, and Figures (TLFs), and submission packages required for various purposes including, but not limited to, Data Monitoring Committee (DMC) data review meetings, Interim Analyses (IAs), and Clinical Study Reports (CSR). The Senior Statistical Programmer will also review and provide input into Statistical Analysis Plans (SAPs), TLF Shells, and various Data Management (DM) documents (e.g., electronic Case Report Forms [eCRFs], edit checks, etc.), support DM with data cleaning activities, use global SAS macros and 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 Senior 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 International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Innovaderm’ standard operating procedures (SOPs) and processes.
More specifically, the Senior Statistical Programmer must:
- 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.
- Act as a Lead Statistical Programmer on multiple single studies.
- Review the statistical programming scope of work and budget at initiation of clinical trials and identify tasks that are out of scope.
- Review and provide input into various DM documents (e.g., eCRF, edit checks, etc.), SAPs, and TLF Shells.
- 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 Innovaderm and/or Sponsor' standards and interpretation of Clinical Data Interchange Standards Consortium (CDISC) SDTM Implementation Guideline (IG) and Controlled Terminology (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 based on protocol, aCRF, SAP, TLF Shells, Innovaderm and/or Sponsor's standards and interpretation of CDISC SDTM IG, ADaM IG, and CT and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable).
- Develop/maintain/validate (as applicable) of SDTM define.XML/.PDF, clinical SDTM Reviewer’ Guide (cSDRG), ADaMs define.XML/.PDF, and ADaM Reviewer’ Guide (ADRG) based on SDTM specifications, ADaM specifications, and Innovaderm and/or Sponsor' standards and interpretation of CDISC Define guidelines and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable).
- Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21 and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable).
- Use global SAS macros to increase efficiency of the statistical programming of SDTMs, ADaMs, derived datasets, and TFLs.
- Act as Unblinded Primary or QC Statistical Programmer for randomization plans and lists, IDMCs, and IAs.
- Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables.
- Participate to internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables, including but not limited to development/ improvement/validation of standard macros, templates, and programming standards and processes.
- Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements.
May also:
- Mentor more junior Statistical Programmers.
- Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Requirements
- Bachelor’s degree in Statistics, Computing Sciences or a related field; master’s degree an asset.
- At least 5 years of clinical research experience in biotechnology, pharmaceutical or Contract Research Organization (CRO) industry, including 4 years of Statistical Programming and 1 year acting as a Lead Statistical Programmer.
- Excellent 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.
- Excellent working knowledge of CDISC standards and guideline; CDISC certification an asset.
- Excellent knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (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; French an asset.
Our company
At Indero, formely 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.
As a Senior Statistical Programmer, you will be eligible for the following perks:
- Permanent full-time position
- Flexible schedule
- Home-based position
- Ongoing learning and development
Work location
The successful candidate for this position is given to work remotely anywhere in Romania
About Indero, formely Innovaderm
Indero, formely 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, Indero, formely Innovaderm continues to grow and expand in North America and Europe.
Indero, formely Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero, formely Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero, formely Innovaderm only accepts applicants who can legally work in Romania
Description de poste
None
Profil recherché
None
Notre entreprise
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