Senior Statistical Programmer

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 Innovadermstandard 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 ReviewerGuide (cSDRG), ADaMs define

XML/

PDF, and ADaM ReviewerGuide (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

Requirements:

Education

Bachelordegree in Statistics, Computing Sciences or a related field; Masters degree an asset

Experience At least 7 years of clinical research experience in biotechnology, pharmaceutical or Contract Research Organization (CRO) industry, including 5 years of Statistical Programming and 2 years acting as a Lead Statistical Programmer

Knowledge And Skills

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;

Our company:

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 India