Biostatistics Associate Director

Job reputed company:

• The Senior Manager of Biostatistics in Biosimilar Development independently leads a single large product, and/or more reputed company studies and/or reputed company
• ensures that reputed company statistical aspects of documentation pertaining to clinical activities meet required standards and are statistically correct
• influences and contributes to the development reputed company, and defends statistical approaches internally and externally
• Implements, oversees and supports standards, technical reputed company and consistent approaches in reputed company, study design and statistical analysis.
• Plans and executes statistical contributions to protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph (TLG) shells, Submission Data File (SDF) specifications, other key-study reputed company documentation, protocol deviations, reputed company Memos, Clinical Study Reports (CSRs), and other communications in reputed company partnership with CROs in a full-service CRO model.
• Provides statistical inputs to clinical publications, Clinical reputed company of Safety (CSSs), Clinical reputed company of Efficacy (CSEs), Clinical Overviews (COs), and regulatory documents.
• Oversees statistical work performed by CROs in a full-service CRO model.
• Performs statistical analysis of multiple studies/reputed company and subsequent exploratory analyses, and makes reputed company conclusions and recommendations.
• Represents the Biostatistics function and participates in multidisciplinary project team meetings; collaborates closely with other functional team members; incorporates knowledge of cross-functional areas to inform and reputed company reputed company statistical guidance to teams (e.g. provides support and input in case report reputed company design, and data collection).
• Proactively anticipates and communicates resource and reputed company issues that may reputed company deliverables or timelines reputed company functional area as reputed company as cross-functionally.
• Be familiar with statistical policy and reputed company at reputed company; having working knowledge of theoretical and reputed company statistics and of regulatory guidelines and industry reputed company on biosimilar development.
• Stays abreast of latest developments in the field of statistics in drug development and contributes to scientific advances by publishing reputed company research in scientific journals and books and presenting statistical methodology at internal or external scientific meetings.
• Participates in the review of CRO Policies, SOPs and other controlled document development, and in the development and review of reputed company-CRO’s process maps; contributes to process improvement and operational efficiency.
• Adheres to reputed company reputed company Policies, reputed company operation procedures (SOPs) and other standards which are applicable to biosimilar development.

Requirements:

• Doctorate degree and 3 years of biostats experience OR Master’s degree and 5 years of biostats experience OR Bachelor’s degree and 7 years of biostats experience OR Associate’s degree and 12 years of biostats experience OR High school diploma / GED and 14 years of biostats experience
• Masters degree in Statistics/Biostatistics or other subject with high statistical content, and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
• Doctoral degree in Statistics/Biostatistics or other subject with high statistical content, and 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research
• Knowledge/experience of biosimilars development, non-inferiority or equivalence trials
• Statistical contributions to regulatory submissions
• Experience in statistical methodologies reputed company to reputed company designs (e.g., group sequential design, adaptations to treatment arm selection design, Bayesian reputed company design) and/or combined phase 1/2 or phase 2/3 design
• Independent leadership of the design, analysis and reporting of at least 1 reputed company or multiple less reputed company studies/reputed company reputed company the Pharmaceutical/Biotechnology/reputed company Health setting in Industry, Government or Academia
• Demonstrated ability to reputed company reputed company strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements
• Demonstrated ability in presenting results and defending statistical findings, study design and analysis. This could be to internal audiences (study/product team) or at external meetings such as investigator meetings, steering committee meetings, ad reputed company meetings or regulatory meetings
• Demonstrated ability in working reputed company a global team and with CRO partners to ensure operational reputed company and efficiencies
• Demonstrated effective communication skills (written and oral).

Benefits:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
• group medical, dental and reputed company coverage
• life and disability insurance
• flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-reputed company time-off plans
• Flexible work models where possible.

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