Manager, Statistical Programming

The Manager, Statistical Programming (SP) will be responsible for providing direct oversight of the statistical programming operations by mentoring and providing relevant training to direct reports, conducting performance reviews of direct reports, collaborating on resource allocation of Statistical Programmers, reviewing scope of work and budget for SP activities of clinical trials, and collaborating in the estimation of change orders and department annual budget. The Manager, SP may also oversee multiple clinical trials and perform Peer Review of SP deliverables to ensure these meet Innovaderm SOPs and quality standards within agreed timelines and budget, and in conformance with applicable Pharmaceutical Industry, ICH, and Regulatory Authority standards and guidelines. Finally, the Manager, SP will lead/oversee internal initiatives to increase efficiency/quality of statistical programming activities/deliverables, act as a SME for SP-related topic(s) and be responsible for the development/maintenance/review of trainings provided to Statistical Programmers as well as of new and/or revised SOPs related to Statistical Programming activities, ensuring these trainings and SOPs are in line with latest ICH Guidelines, Regulatory Authority requirements, and Innovaderm GPP.

This role will be perfect for you if:

• You enjoy managing team members and improving continuously
• You are a good Statistical Programmer interested in working with a small yet Global team, in a mid-sized company
• You have a preference for a work environment where you will work on a large variety of programming deliverables

RESPONSABILITIES

More specifically, the Manager, Statistical Programming will:

• Provide direct oversight of statistical programming operations by mentoring and coaching direct reports, 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, conducting performance reviews of direct reports, collaborating on resource allocation of Statistical Programmers, reviewing the statistical programming scope of work and budget and collaborating on change order estimation, collaborating on the planning of the Biostatistics team annual budget, ensuring general financial health of studies by monitoring HPIs and KPIs, and supporting Lead Biostatisticians, Statistical Programmer Oversights, and Lead Statistical Programmers with de-escalation of potential escalations to prevent escalations and contributing to escalation successful resolution.
• Act as a Statistical Programmer Oversight on multiple studies, including program of studies.
• Perform Peer Review of aCRFs, SDTMs, ADaMs, define.XMLs, cSDRGs, ADRGs, P21 reports, and TLFs according to protocol, SAP, TLF Shells, and Innovaderm and/or Sponsor' standards and interpretation of SDTM IG and CT.
• Identify/lead/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.
• 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 statistical programming-related topic.
• Be responsible for the development/maintenance/review of trainings and SOPs provided to Statistical Programmers, ensuring these trainings and SOPs are in line with latest ICH Guidelines, Regulatory Authority requirements, and Innovaderm GPP.

May also:

• Act as Innovaderm Statistical Programming representative during internal/external audits and inspections,
• Act as the system owner of a Computerized System and perform CSV,
• Act as a Lead or Support Statistical Programmers on multiple clinical trials.

IDEAL PROFILE

Education

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

Experience

• At least 10 years of clinical research experience in biotechnology, pharmaceutical or CRO industry, including at least 7 years of Statistical Programming experience and 3 years of management experience.
• 3 years of management experience.

Knowledge and skills

• Experience with resource allocation and budget planning an asset.
• Extended exposure to clinical trial data, SAP, TLF Shells, and specifications.
• Excellent working knowledge of SAS; SAS certification an asset.
• Knowledge of XM programming an asset.
• Excellent working knowledge of CDISC standards and guidelines; 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 Good Programming Practices (GPP).
• Very organized and detail-oriented, with effective project planning and time management skills.
• Ability to work in a 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 the position of Manager, Statistical Programming, you will be eligible for the following perks:

• Permanent full-time position
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
• Ongoing learning and development

Work location

This position may be based at our headquarters in Montreal, or remote anywhere in Canada.

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.