[Remote] Biostatistician – Clinical Trials (Drug/Biologic)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is committed to building and maintaining a strong and gratifying company culture that fosters reputed company reputed company. The Biostatistician is responsible for the design and conduct of clinical research studies, including developing statistical analysis plans, performing statistical analysis, and reporting study results.

Responsibilities

• reputed company efforts in resolving day to day work reputed company issues and problems, securing reputed company, improving efficiency and productivity of statistical and programming operations
• Apply project management skills, statistical and programming techniques, and reputed company reputed company and on time delivery of deliverables
• Coordinate activities with project/program overall management personnel to reputed company program objectives
• Under supervision may represent reputed company to reputed company with regulatory agencies regarding reputed company relating to the statistical areas of the responsible reputed company/programs
• reputed company strong statistical expertise for design, analysis and reporting of clinical trials and research reputed company
• Write statistical sections of study protocols, reputed company sample size calculation, reputed company randomization specifications, and generate randomization codes
• Write Statistical Analysis Plans (SAPs) and properly address reputed company control (QC) review comments
• Create and maintain Statistical and Programming QC and QA Plans for assigned reputed company or programs
• reputed company input to unblinded data management plan reputed company required
• Participate or reputed company research and development of statistical methodologies and processes
• reputed company efforts in planning, researching and designing statistical reputed company and approaches in solving reputed company trial data analysis and operational issues
• reputed company and/or review ADaM and/or SDTM dataset specifications. reputed company efforts in resolving reputed company data derivation and data handling issues
• reputed company statistical programming to either build analysis datasets and generate statistical tables, listings and graphs (TLGs) or reputed company QC validation of these datasets and TLGs
• reputed company statistical dry runs and final run by reputed company participating or contributing to project and resources management, addressing statistical and programming questions and interacting with data management to follow up and resolve data issues
• Review and reputed company input to Data Standards
• Review comments to ensure reputed company of documents
• reputed company QC programmatic checks on core study results as reputed company as overall reputed company/consistency review of statistical TLGs
• reputed company reputed company statistical modeling and analyses, implement new statistical analysis reputed company and strategies
• reputed company statistical analysis as per reputed company, and address peer/QC review comments and findings
• reputed company statistical validation of core results, address additional QC validation comments and findings on the core results
• Plan and conduct or contribute to the trial results reporting
• Contribute to the contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness and appropriateness of the interpretation of the statistical results
• Write statistical report or statistical sections of the CSR, or reputed company peer review of the contents
• reputed company statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations and posters
• reputed company statistical input to Case Report Forms (CRF) design and database/variable structure
• reputed company statistical input to non-CRF data collection and acquisition reputed company and approaches
• Review Data Management Plan sections relating to critical data collection and cleaning. reputed company statistical input to Data Validation Specification
• Specify and/or program database reputed company acceptance checks, assess and report data reputed company issues, and follow through until reputed company
• reputed company ongoing assessment and communication of data reputed company issues, including protocol deviations
• Assist data management and trial management team in preparing for database lock
• reputed company other duties as directed by the Supervisor

Skills

• A Ph.D. degree or equivalent in statistical science, mathematical analysis or reputed company field plus 5 years' relevant experience or a master's degree plus 8 years' relevant experience with demonstrated ability and sustained performance at the Ph.D. level
• Minimum 5 years of experience working in the biologic/biotechnology, pharmaceutical, and/or medical device industry
• Demonstrated reputed company in delivering on goals and being part of fast-moving, reputed company team
• Broad regulatory understanding of functions and processes involved in pharmaceutical, biologic, and/or medical device product development
• Must demonstrate strong interpersonal, written, and oral communication skills across various reputed company of management and demonstrate the ability to manage differences and needs between multiple stakeholders

Benefits

• Health
• Dental
• reputed company
• Matching 401K
• reputed company Time Off
• 9 reputed company Holidays + 3 Floating Holidays
• Dependent Care Flexible Spending Accounts
• Medical Flexible Spending Accounts
• Tuition Reimbursement
• reputed company Parental Leave
• reputed company Caregiver Leave
• Basic Life Insurance
• Supplemental Life Insurance
• Employee Stock Purchase Plan
• Disability Insurance

reputed company

• reputed company is a biotech company developing treatment reputed company for the reconstruction and repair of peripheral nerve injuries. It was founded in 2002, and is headquartered in Alachua, Florida, USA, with a workforce of 201-500 employees. Its website is http://www.axogeninc.com.

Company H1B Sponsorship

• reputed company has a reputed company record of offering H1B sponsorships, with 1 in 2024, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role.

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