Principal Biostatistician

Hi there!

Are you looking to join an organization that has its eye on meteoric growth? How about a company that is focused on employee growth and development? What about gaining experience working with Oncology? If you answered yes to any of these questions, then this opportunity just might be for you!

I am partnering with a company on the east coast looking to grow their biometrics team with the addition of a Principal Biostatistician. In the role of Senior Biostatistician, you will serve as a lead statistician for one or more projects in clinical development and be responsible and accountable for all statistical aspects for the assigned projects throughout development phases.

What you will be doing:

• Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations.
• Lead assigned projects by applying project management skills, statistical and programming techniques; achieve quality and on time delivery of deliverables, earn client's trust and repeat business.
• May take on the role of a Lead Biostatistician for a developmental program with more than one or two trials, leading other Biostatisticians and coordinating activities with project/program overall management personnel to achieve program objectives.
• May represent the company in client meetings. Under supervision may represent the company to interact with sponsor and/or regulatory agencies regarding matters relating to the responsible projects/programs
• Provide strong statistical expertise for design, analysis and reporting of clinical trials and research projects, and supervision for junior and intermediate Biostatisticians.
• Write statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes.
• Write Statistical Analysis Plans (SAPs) and properly address quality control (QC) review comments.
• Create and maintain Statistical and Programming QC and QA Plans for assigned projects or programs.
• Provide input to unblinded data management plan when required.
• Participate or lead research and development of statistical methodologies and processes.
• Lead efforts in planning, researching and designing statistical methods and approaches in solving complex trial data analysis and operational issues.
• Develop and/or review ADaM dataset specifications. Lead efforts in resolving complex data derivation and data handling issues.
• Perform statistical programming to either build analysis datasets and generate statistical tables, listings and graphs (TLGs) or perform QC validation of these datasets and TLGs.
• Lead statistical dry runs and final run by actively participating or contributing to project and resources management, addressing statistical and programming questions and interacting with data management to follow up and resolve data issues.
• Review and provide input to the Analysis Data Reviewer's Guide, discuss and incorporate Data Standards Reviewer's review comments to ensure quality of the document.
• Perform 3rd level QC programmatic checks on core study results as well as overall quality/consistency review of statistical TLGs.
• Act as a Lead Biostatistician for projects and programs, provide guidance to the Biostatisticians and Programmers supporting the projects and programs.
• Perform complex statistical modeling and analyses, implement new statistical analysis methods and strategies.
• Perform statistical analysis as per SAP, and address peer/QC review comments and findings.
• Perform statistical validation of core results, address additional QC validation comments and findings on the core results.
• Plan and conduct or contribute to the trial results reporting/dissemination meetings.
• Contribute to the contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness and appropriateness of the interpretation of the statistical results.
• Write statistical report or statistical sections of the CSR, or perform peer review of the contents.
• Perform statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations and posters.
• Provide statistical input to Case Report Forms (CRF) design and database/variable structure.
• Provide statistical input to non-CRF data collection and acquisition methods and approaches.
• Review Data Management Plan sections relating to critical data collection and cleaning. Provide statistical input to Data Validation Specification.
• Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution.
• Perform ongoing assessment and communication of data quality issues, including protocol deviations.
• Assist data management and trial management team in preparing for database lock.
• Properly archive study files in accordance with trial sponsor's requirements.

What you bring to the table:

• A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 3 years' relevant experience or a master's degree plus 6 years' relevant experience with demonstrated ability and sustained performance at the Ph.D. level.

What they bring to the table:

• Competitive Compensation (Paid time off, Paid holidays, bonus program, equity award, 401k match)
• Competitive benefits package (Health, dental and vision insurance Health Savings Account (HSA) HSA employer contributions Flexible Spending Accounts)
• A culture and work environment that recognizes employees as their most valuable asset
• Career development and training

If you are having difficulty in applying or if you have any questions, please contact Hunter Lux at (+1) 213-294-2997 or h.lux@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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