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.
This position will oversee all statistical aspects of assigned projects & be responsible for introducing and applying new methodology where appropriate. Statisticians serve as consultants to our clients and are responsible for the conduct of the statistical analyses of our client's research & development projects. Ultimately, our Statisticians ensure that activities and processes performed are conducted according to company and client's SOPs.
This is a 2-3 month contract opportunity. Preference location will be one of our US offices either in RTP, North Carolina or North Houston, Texas.
Serve as the primary contact to clinical operations, data management, programming, medical writing, regulatory & other departments for all matters pertaining to statistics.
Consult on clinical trial design, sample size estimates and statistical methodology
Provide statistical input regarding clinical trial design, statistical analysis, reporting, and interpretation, etc.
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, being able to accurately interpret & clearly communicate statistical results & concepts.
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 (e.g. statistical methodology standards, standard data presentations, standard CRFs, etc.)
Analyze clinical trial data producing accurate results representing the outcome of the trial.
Other duties as assigned
Additional Levels of Responsibility
Responsible for statistical deliverables for assigned projects.
Responsible for statistical input to clinical study reports and other reports.
Serve as the statistical representative on multi-disciplinary teams preparing protocol; responsible for statistical input.
Mentor less experienced statistician within project activities.
Participate in interdepartmental processes.
Provide statistical input into other disciplines and participate in interdepartmental processes.
Contact with clients and regulatory agencies across multiple disciplines.
Contribute to the review and amendment of departmental processes and supporting documentation.
Contribute to proposal activities and client presentations as needed.
Represent Biostatistics during project driven client audits as needed.
Reports directly to Director of Biostatistics
Liaise with all facets of the organization
MS/PhD in statistics or related fields
PhD in statistics or related field with 6+ years of experience or an MS in statistics or related field with 8+ 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 / interpersonal skills for effective client consultations
Ability to manage concurrent projects.
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.