Biostatistician Manager, Clinical Affairs (Remote/Flexible) US - Massachusetts

Job Title: Biostatistician Manager, Clinical Affairs 

Department: Clinical 

FLSA Status: Exempt 
 

Position Overview:  

The newly created Biostatistician Manger role will report directly to the Senior Manager, Global Clinical Affairs Data.  This position will play a critical role in leading the team and providing expert statistical support for internally sponsored, real-world evidence (RWE), and external clinical studies.  The position requires a deep understanding of statistical methodologies, sample size calculations, and regulatory requirements within the medical device industry.  The position requires strong leadership skills, the ability to navigate complex analyses, and proficiency in statistical software.   

The Biostatistician Manager will collaborate closely with cross-functional teams to ensure the successful development and approval of medical devices.  In addition, this role will demonstrate strong communication/presentation skills and will support senior leaders in data analytics.   

Responsibilities: 

• Lead and manage the biostatistics team, providing guidance and mentorship to junior biostatisticians. 

• Develop and implement statistical methodologies for sample size calculations and power analysis. 

• Generation of randomization schedules. 

• Order, collate and interpret large volumes of diverse data and perform exploratory and confirmatory statistical analysis for studies. 

• Manage various datasets, determine summary statistics, conduct hypotheses testing, estimate statistical models, report formats and other analysis considerations.  

• Design and conduct complex statistical analyses for clinical studies, RWE, and other data needs. 

• Prepare statistical analysis plans including development of well-presented mock-up displays for tables, listings, and figures 

• Review and provide input to study protocols, and clinical study reports. 

• Collaborate with cross-functional teams, including Regulatory Affairs, R&D, ADO, and Marketing, to ensure robust statistical support for product validation and claims. 

• Ensure compliance with regulatory requirements and industry standards for statistical practices. 

• Present findings and statistical insights to stakeholders, including senior management and regulatory bodies and effectively communicate statistical concepts. 

• Stay updated with the latest advancements in biostatistics and medical device regulations. 

• Deliver special projects / ad-hoc reporting as needed. 

• Develop and maintain internal SOPs to establish formal procedures ensuring the quality of statistical aspects of studies 

Education and Experience: 

• Masters or Ph.D. in Biostatistics, or Statistics. 

• Minimum of 6+ years of experience in biostatistics within the medical device industry. 

• Proven experience in navigating complex statistical analyses and sample size calculations. 

• Strong knowledge of clinical trial design and regulatory requirements. 

• Strong knowledge of statistical methodologies, experimental design, and analytical and problem-solving abilities. 

• Effective communication skills, both written and verbal. 

• Ability to work collaboratively in a fast-paced, multidisciplinary environment. 

Skills/Competencies: 

• Proficiency in statistical software, including SAS, R, SPSS, and other relevant tools. 

• Excellent leadership and team management skills with the ability to multi-task. 

• Diabetes experience a plus. 

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). ## LI-Remote