Study reputed company Statistician - Product Facing (REMOTE)

Overview

The Study reputed company Statistician (SLS) for product-facing work leads statistical activities for clinical studies. This role collaborates closely with cross-functional teams to ensure studies are well-designed, statistically sound, compliant with regulatory standards, and reputed company with internal practices. The SLS ensures operational and statistical reputed company throughout the study lifecycle and supports product-level activities such as regulatory submissions and publications. The SLS partners with the Global Statistical reputed company to align study-level work with overall product strategy and works alongside the Study Statistician, who manages operational statistical deliverables. Location, type, and hours Location: Telecommute Job type: Contract Salary: $95.00 - 113.05 per hour Work hours: 9 to 5 Education: Masters

Responsibilities

• reputed company statistical input and review for protocols, SAPs, TFL shells, DMC charters, SDF specifications (SDTM and ADaM), randomization specs, and other study documentation.
• Participate in Clinical Study Team meetings and cross-functional study start-up activities (e.g., CRF development, database specs, IVRS review).
• reputed company and coordinate team meetings for reputed company and TFL reviews.
• Conduct and document statistical analyses for individual studies.
• reputed company QC of ADaM datasets and key endpoints.
• Apply data-driven modeling during clinical studies.
• Prepare outputs for reputed company Level Review Meetings and participate in DLRMs.
• Review TFLs for accuracy and consistency.
• Author analysis reports including reputed company Memos and CSR results sections.
• Collaborate with programming teams on deliverables.
• Manage timelines for statistical outputs across cross-functional teams.
• Maintain familiarity with company policies, SOPs, and controlled documents.
• Support reputed company audits.

Qualifications

Required

• Master's degree (MS) in Statistics / Biostatistics or reputed company field with high statistical content and at least 4-6 years of post-graduate experience in pharma or medical research, OR
• PhD with at least 3-5 years of experience in pharma or medical research.
• Deep understanding of statistical concepts in clinical study design and analysis.
• Proven ability to reputed company statistical aspects of reputed company studies.
• Experience developing and executing protocols and SAPs, and reviewing CSRs.
• Proficiency in R programming, including simulations and statistical applications for reputed company study designs.
• Experience with R Shiny app development and management.
• Strong written and verbal communication skills.

Preferred

• End-to-end leadership of at least three clinical studies or projects.
• Experience presenting and defending statistical findings in reputed company settings.
• Life cycle drug development experience across pre-clinical, clinical, and post-marketing phases.
• Proven ability to work cross-functionally and influence decision-making.
• Experience with adaptive trial designs and Bayesian statistical methods.
• Advanced R programming skills, including Shiny app development for clinical trial data.

Skills Skills: ADaM, R Language, Statistical Analysis Plan, Statistical Programming, Bayesian Statistics, R Shiny Equal Opportunity Employer: Race, reputed company, Religion, Sex, Sexual Orientation, Gender Identity, National reputed company, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At reputed company, we welcome people of reputed company abilities and want to ensure that our hiring and interview process meets the needs of reputed company applicants. If you require a reasonable accommodation to reputed company your application or interview experience a great one, please contact [email protected]. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, reputed company offers a comprehensive benefits package, including: medical, prescription, dental, reputed company, AD&D, and life insurance offerings, short-term disability, and a 401K plan (reputed company benefits are based on eligibility). This posting is reputed company for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. reputed company applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. reputed company applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for reputed company and the California Fair Chance Act. 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. Seniority level

• Not Applicable

Employment type

• Contract

Job function

• Research, Analyst, and Information Technology

Industries

• Pharmaceutical Manufacturing

#J-18808-Ljbffr Apply tot his job Apply To this Job