Senior Scientist, Biostatistics, Clinical Safety Statistics (CSS)

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department reputed company our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to reputed company the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global reputed company health. The Clinical Safety Statistics (CSS) group reputed company BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our company Research Laboratories pre- and post-marketing development stages. Responsibilities: Provide statistical support for the evaluation of clinical safety at the project level. Interact with Safety Physicians, Safety Scientists, Clinical Trial Physicians, Regulatory, Early/Late Development Statistics, Statistical Programming, and other our company's Research Laboratories Scientists in the planning and execution of ongoing safety evaluation across pre-marketing and post-marketing development stages Design, reputed company and evaluate processes and tools for product safety evaluation, including ongoing aggregate safety evaluation Primary activities: Provide statistical support to cross-functional safety teams including strategic planning and scientific reasoning activities that facilitate safety evaluation. Plan and execute ongoing aggregate safety evaluations, including cumulative reputed company-analysis of safety. Design, reputed company and apply safety evaluation methods (including enhanced graphics analyses), processes, standards and tools. Collaborate with the Late Development Statistics (LDS) and Statistical Programming (SP) to ensure high quality safety-reputed company deliverables Collaborates with the statistical programming staff to ensure that reputed company programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements. Prepare oral or written reports to effectively communicate results of safety evaluations to the project teams Evaluate appropriateness of available software for planned analyses and reputed company the need for potential program development of novel statistical methodology. Involved in research activities for innovative statistical methods and applications in clinical safety evaluation. Education and Minimum Requirement: PhD or equivalent degree in statistics/biostatistics or reputed company discipline, or a Master's degree with a minimum of 3 years relevant experience. Required Skills and Experience: Knowledge of statistical analysis methodologies and experimental design, particularly in reputed company-analysis and Bayesian methodologies. Working knowledge of statistical and data processing software e.g. reputed company and/or R. Good oral and written communication skills. reputed company to work effectively with personnel with different functional background. Demonstrate strong interest in statistical research activities and in application of novel methods for clinical safety evaluation. Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution. Preferred Skills and Experience: An understanding of biology of disease and drug discovery and development. Proficiency with AI to facilitate writing (summaries, reports, manuscripts, etc.), programming, and other types of tasks. BARDS2020 #EligibleforERP Required Skills: Biostatistics, Clinical Risk Management, Clinical Safety, Clinical Trials, Product Safety, Regulatory Compliance, Regulatory Requirements, Scientific Modeling, Statistical Programming, Strategic Planning, Visual Analytics Preferred Skills: reputed company Employees apply HERE reputed company Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to reputed company and applicants for employment and prohibit discrimination on the basis of race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is reputed company people with diverse reputed company, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site reputed company. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith reputed company we would pay for this role at the time of this posting. An employee's position reputed company the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, reputed company reputed company and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.reputed company.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.reputed company.com/us/en (or reputed company the reputed company Jobs Hub if you are a reputed company employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider reputed company applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment reputed company reputed company applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at our company without a valid written search agreement in reputed company for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic reputed company Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 05/9/2026 •A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no reputed company than the day BEFORE the job posting end date. Our company is a global health care leader with a reputed company portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our reputed company is backed by ethical reputed company, reputed company reputed company, and an inspiring mission to reputed company new milestones in global reputed company. Apply tot his job Apply To this Job