Senior Biostatistician

Hiring By - Biostaffic


Job Highlights

Not Disclosed

Remote Job

Mid-Senior level

Posted 4 months ago
Job details

Job Description: The Biostatistician is responsible for providing the statistical expertise for company products within one or more therapeutic areas. This role will lead protocol development, analysis plans and file/report specifications, and review study setup activities including but not limited to randomization, CRFs and data edits and serve as lead biostatistician for assigned project(s). You will perform statistical analyses, interpret statistical results, and prepare clinical study reports including integrated summaries for submissions as appropriate.

  • Represent Biostatistics on Project Teams; provides statistical expertise to support clinical development objectives and strategy
  • Define statistical methodology, analyzes data, and reports results and contributes to the strategic planning and execution of the clinical development plan for the assigned project (e.g. statistical consideration of synopses or protocols, statistical analysis plans, etc.); ensures the quality of their deliverables.
  • Assist responses to addressing statistical issues are part of regulatory, legal, or other challenges to the company’s products or processes; may represent Biostatistics in key meetings as assigned
  • Serve as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel, and acts as an internal consultant, as assigned, on broad statistical issues that impact on the pharmaceutical/Biotechnology industry
  • Participate in approved process improvement initiatives.
  • Conducts modelling and simulations as needed
  • Promote the use of innovative statistical methodology approaches by identifying, adapting, developing, or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Biometrics department through her/his expertise and customer orientation.
  • Familiarity with moderately complex statistical methods that apply to Phase I-IV clinical trials

Preferred Experience:

  • Experience in statistical or biostatical analysis supporting clinical trial operations for the pharma/biotech industry
  • Past regulatory interactions preferred
  • Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them.
  • Ability to develop innovative/creative statistical/technical solutions to complex problems.
  • Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies.
  • Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas.
  • Proficient with SAS, S-Plus/R, Sample size calculation software (e.g., East, PASS, NQuery)
  • Knowledge of CDISC data standards
  • Ability to write statistical code and documentation

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No


  • Mid-Senior level

Remote Job:

  • Yes

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview
Penfield Search Partners Ltd
Penfield Search Partners Ltd

Current Openings: 0

Penfield Search Partners Ltd. is an executive recruiting firm dedicated to personalized recruitment services; specializing in three specific areas: ~ Property and Casualty Insurance ~ Pharmaceutical, Biotech and Life Sciences ~ Contract Staffing Solutions Our Insurance principals, Karen McCorkindale, Andy Davis and Sean deGroot have recruited together for nearly two decades; our Pharmaceutical and Life Sciences practice is headed by principals Kyle Diamond, Kevin McGrath, and Barbara Day with over 35 years of combined industry expertise. Property and Casualty Insurance - Our relationships include carriers, retail and wholesale brokers, corporate risk buyers and consultants, as well as reinsurance entities. In addition to our broad capabilities, we are recognized as the “go to” firm in the management and professional liability niche markets. Pharmaceutical, Biotech and Life Sciences – Our relationships include many of the leading pharmaceutical and biotech companies nationwide. Our strength is our niche expertise in sales analytics, marketing sciences, forecasting, market research, marketing, health economics, outcomes research, clinical statistical programming, biostatistics, and market access. We are a seasoned team of specialists with knowledge of the influencers, thought leaders and decision makers in the industry. Contract Staffing Solutions - our newly launched group is headed by Directors Michelle Meyer and Angie Foster. INSURANCE Property and Casualty, Risk Management, Underwriting, Brokerage, D&O and E&O PHARMACEUTICAL Commercial - Market Research, Marketing, Marketing Science, Sales Analytics, Forecasting HEOR – Real World Evidence, Outcomes Research, Field Outcomes, Market Access Programming – Statistical Programming, Data Standards, Database Programming Statistics – Biostatistics, Pre-clinical/Discovery, Manufacturing CONTRACT STAFFING SOLUTIONS Biostatistics, Statistical Programming, Data Standards, Database Programming, Data Management
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