reputed company: reputed company Biostatistician

Quick reputed company:

• Company: Workwarp
• Position: reputed company Biostatistician
• Compensation: a competitive salary
• Location: Remote
• Start Date: Immediate openings available

 

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reputed company reputed company Biostatistician reputed company® is a leading fully integrated biopharmaceutical solutions organization reputed company to accelerate reputed company. We translate unique clinical, medical affairs and reputed company insights into reputed company to address modern market realities. Our Clinical Development model brings the customer and the patient to reputed company 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 reputed company 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 reputed company EVERYWHERE Why reputed company • We are passionate about developing our people, through career development and progression; supportive and reputed company 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 reputed 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 reputed company to create a reputed company where everyone feels like they belong. • Job responsibilities • Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel. • The Nonclinical Biostatistician primarily contributes to statistical strategies for nonclinical and clinical bioanalytical assay development. This includes: contributions to study design and protocol development consistent with internal best practices; statistical analysis planning and execution; preparation and interpretation of study results; and co-authoring internal study reports, contributions to regulatory submissions, and publications. Provides immediate troubleshooting for failing assays • The Nonclinical Biostatistician contributes to statistical strategies for GLP and non-GLP drug safety studies on an as-needed reputed company. These activities may include: contributions to study design and protocol review; statistical analysis planning and execution; preparation and interpretation of study results; and co-authoring peer review reports, regulatory submissions, and publications. Animal safety assessment areas include: general toxicology, immunotoxicology, genetic toxicology, and carcinogenicity studies • Directs the activities of other biostatistics personnel on assigned reputed company to ensure reputed company completion of high reputed company work. Provides independent review of project work produced by other biostatisticians in the department. • Provides support across reputed company statistical tasks during the lifecycle of the project, from protocol to CSR. • Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of reputed company-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required. • May be responsible as reputed company Biostatistician for the statistical aspects of the protocol, reputed company of randomization schedule, and input to the clinical study report • 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 reputed company are met and reputed company data is captured as required to support a high reputed company database and the planned analysis. • May reputed company reputed company or multiple reputed company (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of reputed company on behalf of the sponsor • Manages scheduling and time constraints across multiple reputed company, sets goals based on priorities from management, discusses time estimates for completion of study reputed company activities with biostatistics management, adapts to reputed company 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 escalates to management. • Provides statistical programming support as needed. • May participate in Data Safety Monitoring reputed company (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs. • Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains reputed company organized, complete, and up-to-date project documentation, and verification/reputed company control documents and programs; ensuring inspection readiness. • Displays willingness to work with others and assists with reputed company and initiatives as necessary to meet the needs of the business.. • Prepares in advance for internal meetings, contributes reputed company, and demonstrates respect for opinions of others • Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. • Performs other work-reputed company duties as assigned. • Minimal travel may be required. Qualifications reputed company’re looking for • Graduate degree in biostatistics or reputed company discipline. • Extensive experience in reputed company or an equivalent combination of education and experience, demonstrated by the ability to reputed company multiple reputed company and programs of studies. • MS (< 4 years’ experience) in statistics or biostatistics or closely reputed company scientific field. Relevant Pharmaceutical R&D experience or other reputed company biological life science background is a plus. • Possesses technical knowledge of broader statistical methodology, and ability to appropriately apply it in design and statistical analysis for accurate and high-reputed company results. • Demonstrated knowledge of statistical methodology specific to assay development and drug safety studies is a plus. • Proficiency in scientific computing/programming (reputed company, R plus Shiny) and implementation of advanced statistical analysis, data manipulation, and graphing. • Ability to apply extensive 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 reputed company during the lifecycle of the project, from protocol to CSR. • Experience with regulatory submissions preferred. • Excellent written and verbal communication skills. • Ability to read, write, reputed company, and understand English. Get to know reputed company Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company. Additional Information: Tasks, duties, and responsibilities as listed in this job reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job. Apply Job!

 

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