Manager, Biostatistics


The Manager, Biostatistics will be responsible for providing direct oversight of the Biostatistics Operations by mentoring and providing relevant training to direct and indirect reports; ensuring all trainings assigned to direct and indirect reports are completed on time; approving timesheets and requests for personal/sick/annual leave of direct reports; contributing to and conducting performance review of direct and indirect reports. He/she will also be collaborating in resource allocation of Biostatisticians, reviewing the scope of work and budget for the Biostatistics study team of clinical trials, collaborating in the estimation of change orders and department annual budget, and ensuring the financial health of clinical trials by monitoring HPIs and KPIs.

 

The Manager, Biostatistics will also lead, perform Peer Biostatistician Review or oversee multiple clinical trials (including program of clinical trials) to ensure Biostatistical deliverables meet Innovaderm quality standards within agreed timelines and budget and in conformance with applicable ICH and Regulatory Authority guidelines and requirements, Pharmaceutical Industry standards and guidelines (e.g., Clinical Data Interchange Standards Consortium [CDISC]), and Innovaderm’ standard operating procedures (SOPs).

 

Finally, the Manager, Biostatistics will lead and/or oversee internal initiatives to increase efficiency/quality of biostatistics activities/deliverables, act as a Subject Matter Expert (SME) for biostatistics-related topic(s) and be responsible for the development/maintenance/review of trainings provided to Biostatisticians and Statistical Programmers as well as of new and/or revised SOPs related to Biostatistics and Statistical Programming activities, ensuring trainings and SOPs are in line with latest ICH Guidelines and Regulatory Authority requirements. 

 

RESPONSIBILITIES

 

More specifically, the Manager, Biostatistics will:

-Adhere and promote company organizational values and related expected behaviors, follow company SOPs for all deliverables, and ensure all trainings assigned to oneself are completed on time.

-Provide direct oversight of biostatistical operations by:

  • Mentoring direct reports and ensuring mentoring of indirect reports (if any) is appropriate, adequate, and efficient.
  • Providing direct reports with appropriate support and trainings, and ensuring support and trainings provided to indirect reports (if any) are appropriate, adequate, and efficient.
  • Ensuring all trainings assigned to direct and indirect (if any) reports are completed on time.
  • Approving timesheets and requests for personal/sick/annual leave of direct reports.
  • Ensuring direct and indirect (if any) reports annual goals are appropriate and align with company organizational values as well as Biometrics department annual goals.
  • Conducting performance review of direct reports and contributing to performance review of indirect reports (if any).
  • Collaborating to resource allocation of Biostatisticians to ensure biostatistics deliverables are sent within agreed timelines.
  • Reviewing the Biostatistics team 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 HPIs and KPIs, and support Lead Biostatisticians with revenue recognition, budget forecast, and invoices initiation (when applicable).
  • Collaborating in the planning of the Biostatistics team annual budget.
  • Acting as Hiring Manager for new Biostatisticians open position(s).
  • Managing biostatistics and/or statistical programming activities and deliverables performed by Biostatistician and/or Statistical Programmer contractors and/or external vendors to ensure outsourced activities/deliverables are conducted according to the Industry and Innovaderm standards.
  • Managing Line Manager, Biostatistics’ direct reports (if applicable) when Line Manager, Biostatistics is not available (e.g., annual leave, time zone difference, etc.).
  • Liaise closely with other Managers and Senior Staff within the Biometrics Department to ensure strong bond between Biostatistics and Data Management

-Act as a Lead Biostatistician, Peer Biostatistician, and/or Biostatistics Oversight on multiple studies, including program of studies, and internal research and development (R&D) projects. 

-Act as Biostatistics primary point of contact for Leads from other departments, Sponsors, and 3rd party vendors for clinical trials.

-Participate to the development of Risk-based Monitoring Plan for clinical trials, ensuring that appropriate critical data are taken into consideration when developing this plan and appropriate monitoring strategy are selected for each of these critical data.

-Calculate or validate sample size calculations.

-Provide input into statistical sections of protocols to ensure statistical designs and planned statistical analyses clearly and robustly address the objectives of clinical trials and program of studies.

-Provide input into various DM documents (e.g., eCRF, completion guidelines, DVS, DTAs, etc.).

-Develop or perform Peer Review of Unblinding Plans, SAPs, and TLF Shells.

-Perform Lead Biostatistician or Peer Biostatistician Review of SDTM trial domains, subset of ADaMs (e.g., ADSL, efficacy, ADaM with complex derivations, etc.) or derived datasets (as applicable), and all TFLs based on the protocol, SAP, TLF Shells, and Innovaderm and/or Sponsor' standards and interpretation of CDISC SDTM Implementation Guideline (IG), ADAM IG, and Controlled Terminology (CT)

-Provide input into statistical sections of clinical study reports (CSRs) to ensure results from statistical analyses are correctly reported and interpreted.

-Conduct statistical analysis for Investigator Initiated Studies (IISs) and/or internal R&D projects.

-Support Lead Biostatisticians, Biostatistics Oversights, Statistical Programmer Oversights, and Lead Statistical Programmers with de-escalation of potential escalations to prevent escalations and/or contribute to successful resolution of escalations, when needed.

-Contribute to the identification of future internal initiatives to increase efficiency/quality of Biostatistics activities/deliverables and oversee the conduct of such internal initiatives.

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

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

-Act as SME and coach for more than one Biostatistics-related topic, including innovative study designs and novel statistical methodologies.

-Responsible for the development/maintenance/review of trainings provided to Biostatisticians and/or Statistical Programmers, ensuring trainings are in line with latest ICH Guidelines, Regulatory Authority requirements, and Innovaderm’ standards and processes.

-Responsible for the development/maintenance/review of new and/or revised SOPs related to Biostatistics and/or Statistical Programming activities.

-May contribute to the development/maintenance/validation of the statistical programming of ADAMs and TFLs for clinical trials.

-May act as the system owner of a Computerized System (i.e., software/tool).

 

REQUIREMENTS

 

Education 

  • Master’s degree or PhD in Statistics, Biostatistics, or a related field with some applied statistics training relevant to the clinical trials.

 

Experience

  • At least 10 years of biostatistical experience in biotechnology, pharmaceutical or CRO industry.
  • Minimum of 3 years of management experience.

 

Knowledge and skills

  • Ability to create and develop high-performing teams; coach and develop team members.
  • Experience with resource allocation and budget planning an asset.
  • Experience with regulatory interactions and submissions across multiple regions.
  • Advanced working knowledge of SAS.
  • Excellent working knowledge of CDISC standards and guideline.
  • Extensive knowledge of drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC), Food and Drug Administration (FDA), and European Medicines Agency (EMA) regulations, guidelines, and electronic data submission requirements.
  • Experience developing strategies in collaboration with other cross-functional leaders an asset.
  • 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

 

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
  • Permanent full-time position
  • Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
  • Offices near public transportation (Sherbrooke metro station or Saint-Laurent metro station)
  • 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 Canada.

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