Job Description

Are you passionate about making a real impact on global healthcare? We are seeking an exceptional Sr Biostatistics Manager (RWE) to join our dynamic Consulting team dedicated to advancing Real-World Evidence (RWE) services. In this pivotal role, you’ll be at the forefront of delivering high-profile, complex RWE studies for some of the world’s leading pharmaceutical and biotech companies.

If you thrive on challenge, innovation, and leadership, this is your opportunity to lead transformative RWE studies, shape post-market regulatory strategies, and contribute to breakthrough scientific publications seen worldwide.

Step into a role where your expertise fuels innovation, your leadership inspires teams, and your work creates a healthier world. If you’re ready to shape the future of healthcare, we want to meet you!

Your responsibilities:

• Lead complex studies or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings
• Lead the development of complex SAPs perform senior review of SAPs developed by other statisticians
• Conduct overall statistical review of Tables Figures and Listings for complex studies prior to client delivery
• Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant
• Present and share knowledge at monthly team meetings and at external scientific meetings and conferences
• Attend bid defense meetings
• Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives

Your profile:

• Advance degree in a relevant field such as biostatistics, computer sciences, etc. (Doctoral degree preferred)
• 5 or more years of solid experience of working as a Lead Biostatistician in either a biotech, CRO or pharmaceutical company
• Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses; SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
• Proven professional experience with SDTMs, ADaM datasets and TFLs
• Proven ability to effectively communicate statistical concepts
• A good knowledge of the overall observational study process
• Competence in the preparation of SAPs, analysis, and reporting
• Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail

Physical Demands/Work Environment:

Work Environment:

• • Work is performed in an office environment with exposure to electrical office equipment.
  • Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

• • Frequently stationary for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Regular and consistent attendance.
  • Varied hours may be required.

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