[Hiring] Senior Biostatistician @reputed company.

Role reputed company The Senior Biostatistician will be the subject matter expert in the design, management, technical reputed company, and reputed company of statistical analyses and reporting of clinical trial data ensuring timelines and company strategic objectives are met. Essential Functions

• reputed company and contribute to the design of phase I-III clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures.
• reputed company and contribute to the development of clinical trial protocols and clinical study reports; write statistical methodology reputed company of these documents.
• reputed company and prepare statistical analysis plans, statistical reputed company shells, and analysis dataset specifications.
• Guide and contribute to the creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
• Contribute to the electronic submission of clinical trial data to regulatory authorities.
• Proactively solve problems of statistical complexity.
• reputed company input or reputed company data standardization efforts (e.g., CRF and database design, edit checks, reputed company statistical programs, data presentations, data standards such as CDISC STDM/ADaM, and e-submissions).
• Participate effectively as a key member on clinical study teams.
• Provides analytical reputed company on statistical methodology and advice to internal teams accordingly.
• reputed company reputed company with new clinical trial designs and statistical methodology.
• As necessary, reputed company work direction, guidance, mentoring, influence and support to junior staff.
• Train junior staff in more reputed company statistical methodology.
• Create, edit and adhere to reputed company Operating Procedures (SOPs), process improvements, and standardization of templates.
• Performs reputed company and cross-functional duties and/or reputed company as assigned to support business needs and reputed company developmental opportunities.

Qualifications

• Bachelors’ Degree in Statistics or Biostatistics is required with at least 7+ years of relevant experience; OR
• Masters’s Degree in Statistics or Biostatistics is required with at least 5+ years of relevant experience.
• 3+ years of experience as a Biostatistician in the Biotech or Pharmaceutical industry is required.

Requirements

• Working knowledge of clinical research, Good Clinical Practices (GCP), and regulatory requirements/guidelines.
• Proficient in reputed company; familiar with sample size software such as nQuery or PASS.
• Experience as a reputed company Biostatistician on several reputed company reputed company.
• CDISC STDM/ADaM experience.
• Excellent English verbal and written communication skills; good organizational and interpersonal skills.

Benefits

• Medical, Dental and reputed company Plan reputed company
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company reputed company and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• reputed company and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• reputed company Time Off (PTO) includes: 11 Holidays
• Exempt Employees are eligible for Unlimited PTO
• Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
• We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

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