Biostatistician II- fully remote!
Thermo Fisher ScientificSalary not specified
Full Time
Mid-level (3 to 4 years), Senior (5 to 8 years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, Clinical Research, BiotechnologyIndustries
Requirements
- Expertise in leading complex studies and submissions with oversight at team/site/staff level
- Ability to develop protocols, review case report forms (CRFs), and develop analysis plans
- Proficiency in providing input or writing specifications for tables and analysis files
- Skills in communicating with clients on study protocol or statistical analysis issues
- Capability to interpret analyses and write statistical sections of study reports
- Experience in controlling costs and maximizing revenue recognition
- Knowledge of programming specifications for datasets, including complex domains and derivations
- Proficiency in writing programming specifications for tables, listings, and figures (TLFs), and checking outputs
- Ability to program complex analysis datasets and TLFs using Bios tools
- Expertise in planning, documenting, and negotiating timelines, forecasting resource needs, and identifying out-of-scope work
- Strong client relationship management skills, serving as primary point of contact and providing oversight
- Experience in knowledge sharing, training staff, mentoring senior staff (including offshore), and contributing to conferences/societies
- Risk management skills, including identifying risks, implementing mitigations, and handling escalations
- Leadership in database lock, unblinding processes, randomization specifications, and Data Monitoring Committees (DMCs)
- Expert statistical input into reviews
Responsibilities
- Lead complex studies and submissions with oversight at team/site/staff level
- Produce high-quality deliverables, complete/review complex tasks, oversee team for accuracy and efficiency
- Perform as lead statistician on complex studies, integrated summaries, or eSubmissions; ensure quality, timelines, budget, SOP compliance, and consistency
- Manage/delegate data quality issue resolutions, prioritize efficiencies across protocols
- Drive statistical discussions, participate in project team meetings, run meetings, provide updates, assess resources, and follow up on actions
- Write and maintain programming specifications for datasets (focus on efficacy), manage derivations and assignments; may program datasets
- Write specifications for TLFs, check outputs, ensure consistency; may program complex TLFs
- Plan, document, and negotiate timelines; forecast resources; identify out-of-scope work
- Serve as primary client contact, build relationships, provide direction/support/oversight on statistical activities, consult on topics, deliver solutions
- Train staff on operational/technical items, provide training materials at various levels, act as SME, mentor staff, contribute to conferences/societies/IQVIA promotion
- Identify and mitigate risks to delivery/quality, handle study-level escalations
- Lead database lock and unblinding processes; participate in randomization team; serve as unblinded lead; attend DMCs
- Provide expert statistical input into reviews of statistical sections
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is this a full-time position?
Yes, this is a full-time employment opportunity.
What is the work arrangement or location for this role?
This information is not specified in the job description.
What key skills are required for the Statistical Scientist role?
The role requires skills in developing protocols and analysis plans, writing programming specifications for datasets and TLFs, statistical analysis interpretation, leadership in complex studies, and client communication.
What is the team structure or leadership expectation in this role?
The role involves leading teams at a staff level, overseeing groups of studies, mentoring staff including seniors and offshore teams, running meetings, and ensuring high-quality deliverables across teams.
What makes a strong candidate for this Statistical Scientist position?
Strong candidates should have experience leading complex studies, delivering high-quality statistical deliverables on time and within budget, building client relationships, and mentoring teams while driving efficiencies.
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