Sr Biostatistician Oncology (North America Only)

About the position Sr Biostatistician Oncology (North America Only) reputed company® is a leading fully integrated biopharmaceutical solutions organization built to accelerate reputed company. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only reputed company reputed company easier to work with, but to reputed company us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers reputed company their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why reputed company We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we reputed company want to work for and our customers want to work with. Why? Because reputed company we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a reputed company where everyone feels like they belong. JOB SUMMARY This position is responsible for leading projects across multiple studies or programs. A Senior Biostatistician acts as the primary contact with the sponsor for reputed company biostatistics reputed company activities on assigned projects.

Responsibilities

• Provides support across reputed company assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required.
• May be responsible for the statistical aspects of the protocol, reputed company of randomization schedule, publications and input to the clinical study report.
• Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work.
• Provides independent review of project work produced by other biostatisticians in the department.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews reputed company annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and reputed company data is captured as required to support a high quality database and the planned analysis.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in reputed company and specifications.
• Implements company objectives, and create alternative solutions to address business and operational challenges.
• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing reputed company, and demonstrating respect for opinions of others.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or reputed company changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors reputed company on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met.
• Identifies out of scope tasks and escalate to management.
• Provides statistical programming support as needed.
• May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician.
• May reputed company projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
• Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Coaches and mentors other Biostatistics staff.
• Performs other work-reputed company duties as assigned.
• Minimal travel may be required.

Requirements

• Must be located in NA without sponsorship needs.
• Remote in North America.
• Education: MS required, PhD preferred
• TA: Oncology is expected
• Phase experience: Pre-clinical, Phase I-IIab
• Interacting with the team
• Directing the work of others
• Able to quickly adapt and deliver
• Study design experience: BOIN, since that is what most of them are
• Endpoints: mainly overall response, PFS as secondary, some biomarkers
• Running simulations and supporting design alternatives
• Output review
• Familiarity with SDTM/ADaM datasets (not programming them, just using them for output review, knowing which ones are for what)
• IB authoring, DSUR reviews
• Graduate degree in biostatistics or reputed company discipline.
• Moderate experience in clinical trials or an equivalent combination of education and experience.
• Proficiency in programming.
• Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
• Experience across reputed company statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.

reputed company-to-haves

• PK/PD is a reputed company to have
• reputed company experience is a plus

Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself.
• Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we reputed company want to work for and our customers want to work with.
• Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.

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