Shortcuts:

IMAGE: Return to Main IMAGE: RSS Feed IMAGE: Show All Jobs

Détails du poste : Associate Director, Biostatistics

Localisation: Montréal, Québec

Description :

Associate Director, Biostatistics

The Associate Director, Biostatistics will have the overall responsibility and accountability of Biostatistics and across all studies in all Phases of development.

 

RESPONSIBILITIES


  • Inspire, lead and develop all functions within Biostatistics by helping formulating a clear vision for the future and attracting and retaining top talent
  • Ensure appropriate statistical designs and analysis tools and processes to clearly and robustly address the objectives of clinical studies and programs.
  • Assist influencing and providing good-faith challenge to the broader clinical organization with respect to clinical development decisions and data interpretation.
  • Lead development and optimization of Biostatistics processes with specific focus on efficiency and quality, while maintaining or exceeding industry best practices.
  • Actively stay abreast of current industry analysis and reporting trends and practices.
  • Evaluate and implement innovative study designs and novel statistical methodologies as appropriate across each of the indications in dermatology.
  • Provide leadership in development of creating and flexible sourcing strategies to meet the evolving demands of the company when required.
  • Lead a framework in close collaboration with functional heads, in which Biostatistics standards (CRF, TFL, programming standards, CDISC) can be developed, approved (including change control) and archived appropriately.
  • Provide oversight of technical and executional issues related to Innovaderm studies including knowledge transfer, facilitation of alignment around processes and deliverables that support regulatory submissions for our clients.
  • Serve as a member of the Protocol Review, Safety Review, as well as other governance committees as designated.
  • Serve as a Biostatistics subject matter expert to the clinical and projects teams as appropriate; Liaise with clients regarding the conduct of statistical methodology, data analysis and interpretation, and regulatory issues.
  • Provide statistical support of the strategic planning, authoring, and review of manuscripts and other scientific data disclosures.
  • Serve as Innovaderm’s representative to represent function at regulatory meetings, inspections/audits, and Company partnerships both internal and external.
  • Liaise with other company functions leaders to influence, shape, and drive unified strategies related to integrated clinical research data, rapid hypothesis generation and other relevant enterprise efforts.
  • Serve as an expert in structuring algorithms for risk based and centralized monitoring.

 

PROFILE:

A Master’s degree in Statistics, Mathematics, or related field; Ph.D. preferred.

Experience:

  • Minimum of 12 years of clinical development and analysis and reporting experience within the biotech/pharmaceutical or CRO industry.
  • Minimum of 2 years senior management responsibility leading through others.
  • Demonstrated success providing statistical, data management and programming leadership via direct reports.
  • Experience in regulatory interactions and submissions across multiple regions.
  • Leadership/participation in industry organizations including subject knowledge and working groups.
  • Experience developing strategies in collaboration with other cross-functional leaders
  • Extensive knowledge of GCP, ICH guidelines, FDA regulations, CDISC standards/implementation guides, 21 CFR Part 11, and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements; In-depth knowledge of the global drug development process.
  • Advanced proficiency in Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS and other relevant statistical software.

Special Skills/Abilities:

Entrepreneurial leadership with the ability to build consensus in a cross functional environment. Significant ability to creatively solve problems in a cross-functional setting. Ability to relate to varied level audiences across the organization. Demonstrated ability to effectively collaborate and influence throughout multiple levels of the organization.

  • Ability to create and develop high-performing teams; coach and develop team members.
  • Excellent oral, written, communication, and listening skills
  • Ability to develop and drive strategy in complex organizational environments
  • Prior experience shaping integrated strategies related to data collection, integration, and analysis with a goal to promote rapid hypothesis generation, testing, and decision making is highly desirable.
  • Ability to make statistical concepts understandable to non-subject matter experts.
  • Comprehensive knowledge of issues surrounding analysis and reporting of clinical trials data.
  • Solid knowledge of process surrounding regulatory submissions.
  • Ability to make tough decisions to drive the right business outcome.
  • Seeks win-win but able to stand ground when necessary.
  • Dynamic self-starter and agile learner.
  • Ability to balance appropriate levels of structure/process with efficiency and simplicity.
  • Knowledge of ICH/EMEA/FDA guidelines.
  • Willingness and ability to travel domestically or internationally as required.
  • Publication record within the statistical or medical literature

We thank you for your application and please note that only those selected for an interview will be contacted. 

Innovaderm only accepts applicants with a work permit for Canada.

Réaliser une action :

IMAGE: Apply to Position




Powered by: CATS - Applicant Tracking System