Pharm-Olam, LLC

Principal Statistician (Open throughout the US, Canada and/or Mexico)*

Job Locations US-NC-Raleigh-Durham | US-TX-Houston | US
Job ID
2021-2701
Category
Biostatistics

Overview

About Pharm-Olam, LLC:

 

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. 

Summary:

The Statistician oversees all statistical aspects of assigned projects. He is responsible introducing and applying new methodology where appropriate. The Principal Statistician 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 Principal Statistician ensures that activities and processes performed are conducted according to company and client’s SOPs. 

 

This is a full-time, direct hire role for a Principal Statistician with a variety of clinical trial experience (Infectious Disease/Vaccine, Rare Diseases, Immunology, Oncology, DSMB, Oncology, etc.). Ideal candidates should possess a strong background leading complex studies, giving consultations to clients & mentoring junior Statisticians. This position is open to experienced industry candidates loctaed in the United States, Canada and/or Mexico. #LI-Remote

Responsibilities

Key Responsibilities: 

  • Serve as primary statistics contact to clinical operations, data management, programming, medical writing, regulatory & other department members with respect to statistical input into clinical trial design, statistical analysis, reporting, and interpretation.
  • Consult on clinical trial design, sample size estimates and statistical methodology.
  • Interact with other departments, such as clinical operations and project management, to ensure a high level of client satisfaction through successful execution of projects.
  • Validate 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.
  • Provide SAS programming support for data analysis and statistical reports as needed.
  • 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.
  • Provide input to SOPs and standardization efforts. 
  • Analyze clinical trial data producing accurate results representing the outcome of the trial.
  • Provide input into statistical SOP and general standardization efforts within the clinical development (e.g. statistical methodology standards, standard data presentations, standard CRFs). 
  • 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. Responsible for same size estimation, study design, and statistical methodology.
  • 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 the review and revision of departmental processes and supporting documentation.
  • 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 duties as assigned

Qualifications

  • MS/PhD in statistics or related fields
  • PhD in statistics highly preferred
  • 8-10 + years of experience in statistics or related field that includes the development of pharmaceuticals, biologics, and/or medical devices.
  • Prior experience as a lead statistician highly preferred.
  • 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.

For Consideration

 

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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