Director, Biostatistics
Amylyx PharmaceuticalsSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, Clinical ResearchIndustries
Requirements
- PhD in Statistics, Biostatistics, or related field or MS in Statistics, Biostatistics, or related field
- PhD: 5+ years industry experience or MS: 7+ years industry experience
- At least 3 years in Phase 2/3 clinical trial experience
- Demonstrated ability to work proactively and independently
- Ability to effectively communicate ideas and manage programmers constructively
- Proficiency in R or SAS for efficacy and safety analyses and data validation
- Understanding of ICH GCP, ICH E9
Responsibilities
- Collaborate with multi-disciplinary project teams to establish project objectives and timelines
- Write the statistical sections of clinical trial protocols, consulting with internal and external experts
- Author statistical analysis plans
- Monitor internal and CRO project activities, including timelines, deliverables, and resource availability
- Collaborate with Data Management, Clinical Development, and Clinical Operations, providing statistical expertise
- Contribute to clinical study reports and other regulatory documents (e.g., NDA, DSURs, Briefing Documents, ISS, ISE)
- Provide guidance and supervision to programmers in authoring analysis dataset specifications and programming/validation of tables, listings, and figures
- Interpret study results and review reports of study results for accuracy
- Support exploratory analyses
- Participate in pre-IND or NDA activities
- Participate in other activities and meetings to support Biostatistics and the Development Team as needed
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is this position remote or home-based?
Yes, the position is home-based in the U.S. or Canada.
What education and experience are required for this role?
A PhD in Statistics, Biostatistics, or related field with 5+ years industry experience, or MS with 7+ years industry experience is required, along with at least 3 years in Phase 2/3 clinical trials.
What key skills are needed for the Principal Biostatistician position?
Key skills include proficiency in R or SAS for analyses and data validation, ability to work proactively and independently, effective communication and management of programmers, and understanding of ICH GCP and ICH E9.
What is the company culture like at IQVIA's DSSS?
The culture emphasizes collaboration with motivated teams in an engaging, fast-paced environment, with a focus on work/life balance, flexible schedules, technical training, research opportunities, and bringing therapies to market.
What makes a strong candidate for this Principal Biostatistician role?
Strong candidates will have the required PhD or MS with specified industry and Phase 2/3 trial experience, proficiency in R or SAS, and demonstrated proactive independence, communication skills, and knowledge of ICH guidelines.
IQVIA
Advanced analytics and clinical research services
About IQVIA
IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.
Durham, North CarolinaHeadquarters
1998Year Founded
$3,526MTotal Funding
POST_IPO_EQUITYCompany Stage
Cybersecurity, Biotechnology, HealthcareIndustries
10,001+Employees
Risks
Rapid advancement of cancer vaccines may disrupt traditional clinical research models.
Proliferation of disparate technological solutions causes technology overload in clinical trials.
Generative AI technologies face challenges in adoption due to data privacy concerns.
Differentiation
IQVIA leverages advanced analytics and big data for life sciences solutions.
The company offers privacy-enhancing technologies to protect individual patient data.
IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.
Upsides
Increased adoption of decentralized clinical trials enhances patient-centric study designs.
AI-driven drug discovery accelerates identification of potential drug candidates.
Expansion of telemedicine facilitates remote patient monitoring and data collection.
Related Jobs
RemoteRemoteDirector, Data and Science (Analytic Solutions)
Verana HealthSalary not specified
- Full Time
- Senior (5 to 8 years), Expert & Leadership (9+ years)
RemoteSenior Biostatistician
Lindus Health$60,000 - $90,000/year
- Full Time
- Senior (5 to 8 years), Mid-level (3 to 4 years)
RemoteSr. Statistical Programmer - FSP - US West Coast Only
Thermo Fisher ScientificSalary not specified
- Full Time
- Senior (5 to 8 years)
RemoteSenior Director, Statistical Methodologist
BiogenSalary not specified
- Full Time
- Senior (5 to 8 years)