Senior Biostatistician

Peak Performers has partnered with a global biopharmaceutical company to assist in their search for a Senior Biostatistician. In this contract position, you will lead statistical support for clinical trials, including statistical design, analysis, and interpretation of results.

Major duties

• Develop and maintain Statistical Analysis Plans (SAPs) and table shells for clinical study reports.
• Oversee and ensure the integrity of data flow through the clinical trial process, from raw data to SDTM (Study Data Tabulation Model) to ADaM (Analysis Data Model).
• Provide statistical programming expertise using SAS and LSAF systems, with the ability to learn and utilize other tools such as R and EAST for advanced statistical analysis.
• Work closely with clinical, regulatory, and data management teams to ensure appropriate statistical methodologies and analyses are applied in line with project goals and regulatory guidelines.
• Provide guidance on the preparation of TLFs (Tables, Listings, Figures), ensuring accurate and timely delivery of statistical output for regulatory submissions and publications.
• Mentor and support junior biostatisticians, fostering a collaborative and efficient team environment.
• Participate in the design, review, and critique of clinical trial protocols, ensuring statistical aspects are well-structured and feasible.
• Interact with external vendors and partners, managing the statistical aspects of outsourced work when necessary.
• Ensure compliance with Good Clinical Practice (GCP) and other relevant regulatory standards.
• Present statistical findings to internal and external stakeholders, including at regulatory meetings, conferences, and other forums.
  
  

What are we looking for?

• MS or PhD in Biostatistics, Statistics, or related field.
• 5-10 years of biostatistics experience in the pharmaceutical/biotech industry, with a focus on clinical trials.
• Expertise in SAS programming for clinical trial data analysis.
• Experience with LSAF systems and familiarity with other tools such as R and EAST for advanced statistical modeling.
• Proficiency in developing Statistical Analysis Plans (SAPs) and table shells.
• Strong understanding of the data flow process, including raw data, SDTM, ADaM, and the preparation of TLFs.
• Familiarity with industry standards and guidelines (e.g., CDISC, ICH E9, GxP, etc.).
• Ability to clearly present complex statistical concepts to non-statistical stakeholders and senior management.
• Strong analytical mindset with the ability to think critically and solve complex statistical challenges.
• Ability to work both independently and collaboratively within cross-functional teams.
• Experience with clinical trial design, regulatory submissions, and knowledge of other statistical software tools are a plus.
  
  

About This Position

• Rate: $85.00 - $100.00/hour
• Length of engagement: ~6 months
• Days/Hours: Monday-Friday/8am-5pm
• This position is hybrid in Waltham, MA
  
  

The Peak Performers difference

• Excellent medical health, dental & vision insurance at 60 days
• Our employees may choose to participate in a 403(b) retirement plan
• Qualified applicants with chronic medical conditions and/or disabilities receive priority placement
• We pay weekly through direct deposit
• In business since 1994 and thousands of job placements
  
  

All employment offers are contingent on the successful completion of a pre-employment criminal background check, in compliance with all applicable federal and state laws.

Applicants for employment with Peak Performers must possess work authorization that does not require sponsorship for a visa now or in the future.

Peak Performers is an equal opportunity employer and will consider all applicants without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Peak Performers does not accept unsolicited resumes from headhunters, recruitment agencies or fee-based recruitment services.

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