The Line Manager, Statistical Programming will be responsible for providing direct oversight of the statistical programming operations by mentoring, reviewing work performed by, and providing relevant training to direct reports; ensuring all trainings assigned to direct reports are completed on time; approving timesheets and requests for personal/sick/annual leave of direct reports; in collaboration with the Manager, Statistical Programming, conducting performance review of direct reports, collaborating in resource allocation of Statistical Programmers, and participating in the hiring process of new Statistical Programmers.

The Line Manager, Statistical Programming will also lead or oversee single and/multiple clinical trials (including program of clinical trials), and perform activities conducted by the Statistical Programming team, working collaboratively across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements, and Innovaderm’ standard operating procedures (SOPs) and processes.

Finally, the Line Manager, Statistical Programming may lead or oversee internal initiatives to increase efficiency of statistical programming activities/deliverables, act as a Subject Matter Expert (SME) for statistical programming-related topic(s), participate to the development/maintenance/ review of new and/or revised SOPs related to Statistical Programming activities as well as of trainings provided to Statistical Programmers related with the latest ICH Guidelines, Regulatory Authority requirements, and Innovaderm’s Good Programming Practice (GPP), SOPs, and processes.

More specifically, the Line Manager, Statistical Programming must:

o  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.

o  Provide direct oversight of statistical programming operations by:

• Mentoring direct reports,
• Reviewing work performed by direct reports and addressing any areas of improvement identified by providing direct reports with appropriate support and trainings to ensure biostatistics deliverables are sent with the highest quality possible,
• Ensuring all trainings assigned to direct reports are completed on time,
• Approving timesheets and requests for personal/sick/annual leave of direct reports,
• Ensuring direct reports annual goals are appropriate and align with company organizational values and Biometrics department annual goals,
• In collaboration with the Manager, Statistical Programming, conducting performance review,
• Collaborating to resource allocation of Statistical Programmers to ensure biostatistics deliverables are sent within agreed timelines,
• Reviewing the statistical programming scope of work and budget at initiation of clinical trials and collaborating to change order estimation, as needed,
• Ensuring general financial health of studies by monitoring high performance indicators (HPIs) and key performance indicators (KPIs),
• Participating in the hiring process of new Statistical Programmers.

o  Act as a Lead Statistical Programmer or Statistical Programmer Oversight on single and/or multiple studies, including program of studies.

o  Review and provide input into various Data Management (DM) documents (e.g., eCRF, edit checks, etc.), Statistical Analysis Plans (SAPs), and Table, Listing, and Figure (TLF) Shells.

o  Support DM with data cleaning activities by programming, reporting, reviewing, and closing statistical data issues in collaboration with other Statistical Programmers and Lead Biostatistician.

o  Develop/maintain/validate/perform Peer Review (as applicable) annotated electronic Case Report Forms (aCRFs) according to protocol and Innovaderm and/or Sponsor' standards and interpretation of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) Implementation Guideline (IG) and Controlled Terminology (CT).

o  Develop/maintain/validate/perform Peer Review (as applicable) of specifications and Primary or QC statistical programming (as applicable) of SDTMs, Analysis Data Models (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).

o  Develop/maintain/validate/perform Peer Review (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 Guidelines and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable).

o  Validate SDTMs, ADaMs, and define.XMLs using Pinnacle 21/perform Peer Review of Pinnacle 21 reports and address any finding appropriately in collaboration with Statistical Programmer counterpart and/or Lead Biostatistician (as applicable).

o  Act as Unblinded Primary or QC Statistical Programmer for randomization plan and lists, IDMCs, and IAs.

o  Contribute to the identification of future internal initiatives to increase efficiency/quality of Statistical Programming activities/deliverables.

o  Lead or oversee 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.

o  Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements.

o  Act as SME for more than one statistical programming-related topic.

o  Participate to the development/maintenance /review new and/or revised SOPs related to Statistical Programming activities.

o  Participate to the development/maintenance/review of trainings provided to Statistical Programmers related with latest ICH Guidelines, Regulatory Authority requirements, and Innovaderm’s GPP, SOPs, and processes.

May also:

o  Collaborate in planning the Biostatistics team annual budget.

o  Manage statistical programming activities and deliverables performed by Statistical Programmer contractors and/or external vendors, ensuring outsourced activities/deliverables are conducted according to the Industry and Innovaderm standards.

o  Participate in cross-functional internal initiatives to increase collaboration between departments, efficiency of Innovaderm’ standards and processes, and clinical trials overall quality.

REQUIREMENTS

Education

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

Experience

• At least 7 years of clinical research experience in biotechnology, pharmaceutical or CRO industry, including 5 years of Statistical Programming.
• At least 3 years of supervisory or project team lead experience preferred.

Knowledge and skills

• Extended 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 integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities.

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

• Flexible schedule
• Vacation
• 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.