Senior Biostatistics Manager RWE

Fortrea; Durham (NC); Remote; USD 90,000 - 150,000; Full time

Job summary

Join a forward-thinking global company as a Sr Biostatistics Manager RWE, where you will lead complex real-world evidence studies for top pharmaceutical and biotech firms. This role offers the chance to develop Statistical Analysis Plans, provide SAS programming oversight, and ensure the successful delivery of impactful studies. Enjoy a rewarding work environment that values work-life balance, offers competitive compensation, and provides excellent training and career development opportunities. If you have a passion for biostatistics and a desire to make a difference, this is the perfect opportunity for you.

Benefits

Pension Contributions

Complimentary Health Insurance

Remote Working Allowances

Flexible Working Hours

Thorough Onboarding

Personal Mentor Support

Excellent Training Opportunities

Qualifications

• 8+ years of experience as a Lead Biostatistician in biotech or pharmaceutical companies.
• Proficiency in SAS for statistical analysis and reporting.

Responsibilities

• Lead complex RWE studies and coordinate activities across multiple locations.
• Develop and review SAPs and conduct statistical reviews of deliverables.

Skills

SAS Programming

Statistical Analysis Plans (SAPs)

Biostatistics

Communication of Statistical Concepts

Organizational Skills

Education

Doctoral Degree in Biostatistics or Related Field

Advanced Degree in Computer Sciences

Tools

SAS

Job description

Sr Biostatistics Manager RWE

As an experienced Sr Biostatistics Manager RWE in our Consulting business supporting our Real-World Evidence (RWE) service, you will be central to the successful delivery of complex RWE studies for renowned, innovative, and global top pharmaceutical and biotech companies. You will have the opportunity to lead RWE studies, support post-market regulatory submissions, and publications.

In this role, you will develop and review Statistical Analysis Plans (SAPs) for data presentation and analyses, and provide SAS programming oversight.

What else can you expect from us?

• Rewarding and meaningful work in an established, diverse, highly profitable, and respected global company
• Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances, etc.
• A genuine work-life balance
• Flexibility in working hours
• A thorough onboarding with support from your personal mentor
• A permanent employment contract with Fortrea
• Excellent training and career development opportunities, as well as support with advancing your individual education

Your responsibilities:

• Lead complex studies or multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight, and attending relevant project meetings
• Lead the development of complex SAPs and 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:

• Advanced degree in a relevant field such as biostatistics, computer sciences, etc. (Doctoral degree preferred)
• 8 or more years of solid experience as a Lead Biostatistician in biotech, CRO, or pharmaceutical companies
• Ability to program in statistical software packages (SAS) used for analyses; proficiency in SAS including procedures like non-parametric analysis, linear and non-linear models, categorical data, and survival analysis
• Proven experience with SDTMs, ADaM datasets, and TFLs
• Effective communication of statistical concepts
• Good knowledge of the observational study process
• Competence in preparing SAPs, analysis, and reporting
• Strong organizational skills, autonomous and collaborative work style, curiosity, and keen attention to detail

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