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
Pharmaceuticals, HealthcareIndustries
Requirements
- BSc or MSc degree in Biostatistics or related field and 10+ years’ relevant experience within the life-science industry, along with at least 2 years’ experience in managing staff
- Familiarity with complex statistical methods that apply to Phase I-IV clinical trials
- In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Familiarity with moderately complex statistical methods that apply to applicable clinical trials
- Strong working knowledge of SAS
- Working knowledge of relevant Data Standards (such as CDISC/ADaM)
Responsibilities
- Manage a team of Biostatistics staff and fulfil the role of site head or functional head within a site
- Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments, and applying advanced statistical methods to project work
- Serve as a resource for the department, ensuring scientific integrity in the application of statistical methodology to clinical trials
- Assist the Director in strategic planning and resource allocation for the department
- Participate as oversight across studies and/or customers including guidance on documentation and output development/review
- Assist the Director in proposal development, project allocation, budget projections, and client presentation, as needed
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the salary for the Associate Director, Biostatistics position?
This information is not specified in the job description.
Is this position remote or hybrid, and where is it located?
The role is home-based/hybrid and located in Germany.
What are the key requirements and skills for this role?
Candidates need a BSc or MSc in Biostatistics or related field with 10+ years of relevant experience in the life-science industry, including at least 2 years managing staff, familiarity with complex statistical methods for Phase I-IV trials, in-depth knowledge of GCP and ICH guidelines, strong SAS knowledge, and working knowledge of CDISC/ADaM standards.
What is the company culture like at IQVIA for this team?
IQVIA offers a collaborative and supportive team environment with camaraderie, professional development, global exposure, variety of therapeutic areas, and access to cutting-edge in-house technology.
What makes a strong candidate for this Associate Director role?
A strong candidate has a BSc or MSc in Biostatistics with 10+ years of life-science industry experience, including 2+ years managing staff, expertise in SAS and clinical trial statistics, and knowledge of regulatory guidelines like GCP and ICH.
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.
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