You will be aligned therapeutically with cross-functional Medical Affairs teams to provide statistical and analytical guidance and support in the development and execution of medical strategies, plans and projects.
Like other team members in Biostatistics, you will be responsible for the statistical integrity, adequacy and accuracy of pre-launch, launch and post-marketing clinical studies other investigations and assessments, including exploratory analyses. As such, you will be a standing member of Biostatistics teams, may be a standing member of the assigned Medical Team, and also participate in other cross-functional projects or working teams.
Given the nature of your position, you will also work closely with your counterparts in Pharmaceutical Development and potentially Pharmaceutical Research and Early Development to align clinical data and statistics across varying drug development phases.
The Biostatistician position is an entry-level position for Biostatistics, where incumbents may have limited related experience and limited exposure to clinical trials.
All Roche employees are expected to effectively contribute to cross-functional collaboration and coordination and comply with all laws, regulations, policies & procedures that govern our business.
In this position, you will be primarily accountable for consistently, effectively:
Contributing statistical and analytical direction, insights, recommendations and overall input into development and execution of 3- and 1-year medical strategies, plans, objectives and projects
Developing, implementing and overseeing timely, thorough, consistent, and quality execution of statistical analysis plans that support medical strategies, plans, projects and objectives and assure statistical integrity, adequacy and accuracy
Providing appropriate biostatistics inputs and direction for the assigned products into a variety of pre-launch, launch and post- marketing medical affairs activities
Participating in exploratory analyses and statistical research
Participating in the ongoing development, refinement and enhancements of departmental methodologies and techniques for biostatistics research, analysis and reporting
Developing and cultivating important working relationships with cross-functional teams and groups
As needed representing U.S. Medical Affairs Biostatistics to global Roche partners and working collaboratively to coordinate and align statistical analysis plans and outcomes at the national and global levels
Staying informed and abreast of the external landscape as it relates to assigned molecules, products, and programs and the associated therapeutic area(s)
As assigned, completing other special projects
Ensuring assigned goals and objectives are met and that assigned projects and other work are completed on time, to high standards and within budget
In this position, you will:
Maintain a high-level of scientific and clinical knowledge in the specific therapeutic area(s) of assignment as well as the highest levels of technical expertise in biostatistics research and analysis
Participate in the development of medical strategies, plans, projects and objectives in the assigned therapeutic area of oncology
As appropriate, gathering and/or consolidating research, analytics and other information to support medical plan development
As assigned, working as part of the cross-functional Medical Affairs Team to develop and contribute to all aspects of the 3- year and 1-year Medical Plans; including statistical and analytical requirements for clinical studies, projects and other assessments, publication planning, interactions and communications with external partners, relevant medical meetings, presentations, other events and forums
As appropriate, working with cross-functional teams and global Roche partners to align Genentech medical and statistical analysis plans at the affiliate and global levels
Participate in development of statistical analysis strategies, objectives and requirements for each clinical trial or other study/investigation for assigned products, including health economics and outcomes research projects:
Providing sound strategic, statistical and scientific input on project objectives, experimental design and data analysis to meet project needs and health authorities statistical and scientific requirements
Working with your manager and others to establish data, analytical, statistical and reporting requirements for each study or other assessment. Includes working with statistical programmers and data management to confirm, build and implement data and systems programs and structuring
Serving as a Biostatistics contact on Study Management Teams (SMTs)
Reviewing all project designs and protocols
With guidance, authoring protocol statistical analysis sections and statistical analysis plans and managing study randomization code generation
When assigned, acting as a Biostatistics liaison for the team and primary statistical point-of-contact for medical monitor inquiries from trial sites, CROs, etc.
Responding to questions regarding statistical protocol inquiries and other related matters
Monitor and oversee pre-launch, launch and post-marketing clinical trials and other studies and assessments through to completion, reporting and publication:
Planning and coordinating a myriad of Biostatistics team activities to ensure successful and timely completion of assigned projects
Conducting ongoing in-depth reviews of data listings. Performing statistical analysis following established methodologies, protocols and procedures to identify key patterns, themes, potential issues, opportunities and results
Reviewing Case Report Forms (CRFs) to ensure that protocol objectives are met and that project standards are maintained
With guidance, authoring statistical analysis results in the clinical study report or other relevant reporting
Managing report development and completion through internal and external reviews
Providing biostatics inputs in response to internal and external questions
As assigned, represent Biostatistics in publication planning, congress and other meeting/association planning and management. Provide biostatistics content and input into publications and internal and external presentations. May also present biostatistics information, plans and results at internal forums
Review materials from other internal partners, as appropriate, to ensure alignment and accuracy with biostatistics strategies, direction and results
PhD. or Masters Degree + 3 years' experience in statistics/biostatistics (PhD is preferred)
Knowledge of ICH-GCP and other relevant standards and guidelines
Sound knowledge of theoretical and applied statistics
Must demonstrate aptitude to understand Phase IV/post-marketing drug development (knowledge of or experience with Phase I - III drug development is preferred)
Relevant therapeutic area knowledge is a plus
Relevant therapeutic experience is a plus
Proven experience in the principles and techniques of data analysis, interpretation and clinical relevance
Proven track record of meeting or exceeding objectives and goals
Strong analytical and problem-solving capabilities and skills
Good business acumen: has working knowledge of the multi-disciplinary functions involved in a company's drug development process, e.g. research, development, clinical operations, biometrics, regulatory, commercial, etc.
Excellent project management skills: can prioritize multiple tasks and goals and ensure the timely, on-target and within-budget accomplishment of such
Good interpersonal, communication and influencing skills: can influence without authority
Good business presentation skills: is comfortable and effective when presenting to others, internally or externally
Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
Willingness to partner with others and a proven track record of collaborative work relationships
Proficient with R, and benefits from working knowledge of SAS. Proficient computer skills, including Microsoft Word, PowerPoint, and Excel.
Business travel, by air or car, is required for regular internal and external business meetings
Roche is an equal opportunity employer.
Research & Development, Research & Development > Biometrics
Hoffmann-La Roche Inc.