Pharm-Olam, LLC

Senior Biostatistician (Contractor)

Job Locations US | US-NC-Raleigh-Durham
Job ID
2022-3119
Category
Biostatistics

Why Pharm-Olam

Pharm-Olam, LLC is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

 

This is Important Work

The Senior Biostatistician oversees all statistical aspects of assigned projects. The employee is responsible for introducing and applying new methodology where appropriate. The Senior Biostatistician serves as a consultant to our clients and is responsible for the conduct of the statistical analyses of our client’s research & development projects. The Senior Biostatistician ensures that activities and processes performed are conducted according to company and client’s SOPs.

 

This is a full-time, contract opportunity (lasting approximately 6 months) for an experienced Senior Biostatistician located in the USA. #LI-Remote

Your Role

  • Serve as the primary contact to clinical operations, data management, programming, medical writing, and regulatory for all matters pertaining to statistics.
  • Interact with other departments, such as clinical operations and project management, to ensure a high level of client satisfaction through successful execution of projects.
  • Review statistical output to ensure that it accurately portrays the outcome of the clinical trial.
  • Relay the Top Line results to the appropriate parties.
  • Review the CSR for accuracy with respect to the interpretation of the statistical analyses.
  • Develop the Statistical Analysis Plan and mock ups of tables, listing, and figures.
  • Work with study team during (e)CRF development to ensure adequacy of data collection with respect to statistical endpoints derivability.
  • Prepare ADaM mapping documentation.
  • Develop and execute QC programs datasets, tables and figures.
  • Act as a representative of the biostatistics department on project teams.
  • Attend project team meetings as necessary.
  • Responsible for statistical deliverables for assigned projects.
  • Responsible for statistical input in to clinical study reports and other reports.
  • Serve as the Biostatistics representative on multi-disciplinary teams.
  • Participate in interdepartmental processes.
  • Provide advice and propose solutions on statistical methodology to Pharm-Olam staff and clients.
  • Interact with clients and regulatory agencies.
  • Contribute to proposal activities and client presentation as needed.
  • Represent Biostatistics during project driven client audits as needed.
  • Serve as a mentor to junior level staff.
  • Other responsibilities as required.

Required Education and Qualifications

  • MS/PhD in statistics or related fields
  • PhD in statistics or related field with 4+ years of experience or an MS in statistics or related field with 6+ years of experience in the development of pharmaceuticals, biologics, and/or medical devices.
  • Prior experience as a lead statistician.
  • Knowledgeable of all phases of clinical studies.
  • Demonstrated problem solving skills and strategic planning ability
  • Practical and technical knowledge of statistical analyses in support of Phase 1-4 clinical trials or medical device studies.
  • Demonstrated ability to effectively communicate to external and internal clients.
  • Good communication skills.
  • Ability to manage concurrent projects.

Apply Now

 

Please apply online at www.pharm-olam.com/careers

 

Pharm-Olam, LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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