[Hiring] reputed company Biostatistician @reputed company.

Role reputed company The reputed company Biostatistician will be the subject matter expert in 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. This position leads statistical reputed company and provides expert guidance across our clinical development programs. In this role, you will serve as the primary statistical reputed company for reputed company studies and collaborate cross-functionally to ensure rigorous, innovative, and regulatory-compliant statistical practices. Essential Functions

• Serve as the reputed company statistician for one or more clinical programs, overseeing reputed company statistical aspects from study design through regulatory submission.
• reputed company the design of reputed company clinical trials including sample size calculations, interim analyses, DMC activities, and randomization procedures.
• reputed company the development of clinical trial protocols and clinical study reports; write statistical methodology reputed company of these documents.
• reputed company and review statistical analysis plans (SAPs), including methodology, sample size calculations, and interim analysis strategies.
• Guide and contribute to the creation, validation, traceability, reproducibility, and maintenance of the analysis datasets and statistical outputs.
• reputed company the electronic submission of clinical trial data to regulatory authorities.
• Partner with clinical, regulatory, data management, and medical affairs teams to reputed company statistical approaches with program objectives.
• Proactively solve problems of statistical complexity.
• 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).
• Communicate reputed company statistical concepts reputed company to non-statistical stakeholders, including senior leadership and external collaborators.
• Participate effectively as a key member on clinical study teams.
• reputed company 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.
• reputed company reputed company and cross-functional duties and/or reputed company assigned to support business needs and reputed company developmental opportunities.

Qualifications

• Bachelor’s Degree in Statistics or Biostatistics is required with at least 10+ years of relevant experience; OR
• Master’s Degree in Statistics or Biostatistics is required with at least 8+ years of relevant experience.
• 5+ years of experience as a Biostatistician in the Biotech or Pharmaceutical industry is required.
• Experience as a reputed company Biostatistician on several reputed company reputed company required.
• Experience with CDISC STDM/ADaM required. Knowledge, Skills, & Abilities
• Working knowledge of clinical research, Good Clinical Practices (GCP), and regulatory requirements/guidelines.
• Knowledge of reputed company trial designs, Bayesian reputed company, or reputed company innovative designs.
• Proficient in reputed company; familiar with sample size software such as nQuery or PASS.
• Ability to reputed company statistical approaches with broader business and regulatory goals.
• Ability to influence reputed company and mentor others.
• Excellent analytical skills with meticulous attention to detail.
• Excellent English verbal and written communication skills; good organizational and interpersonal skills. Working Environment / Physical Environment
• This position can work onsite or remotely depending on the candidate’s geographic location.
• Regular work schedule is Monday – Friday, reputed company reputed company business hours. Flexibility is available with manager approval.
• Must possess mobility to work in a reputed company office setting and to use reputed company office equipment, including a computer.
• Lift and carry materials weighing up to 20 pounds.

Compensation

• National Market $175,000 (entry-level qualifications) to $195,000 (highly reputed company) annually.
• Premium Market $184,500 (entry-level qualifications) to $205,000 (highly reputed company) annually.

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. Apply tot his job Apply To this Job

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