Principal Statistician

NCBiotech; Durham (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

NCBiotech is seeking a Biostatistics Project Lead to contribute to statistical activities for global clinical trials and collaborate with international statisticians, programmers and data managers.

You will act as a communication line for project teams, develop and review SAPs per CDISC ADaM, review tables/listings, lead SAS programmers, and participate in audits and QA. MSc in Statistics and regulatory knowledge are required.

Qualifications

• MSc in Statistics or equivalent.
• Expert knowledge of statistical methods used in clinical research.
• Expert SAS programming skills.
• Expert CDISC ADaM standard knowledge.
• Experience with adaptive designs.
• Experience with sample size calculations.
• Knowledge of FDA/EMA/ICH regulations.
• Ability to apply advanced statistics to studies.
• Strong presentation and communication skills.

Responsibilities

• Act as a communication line for project teams, clients, vendors and internal team on statistical questions.
• Conduct statistical analysis for clinical trials including interim, final, DSMBs/DMCs and PK analyses.
• Develop and review study protocols and SAPs per CDISC ADaM and project documents.
• Review statistical deliverables such as tables, figures, listings and analysis datasets.
• Lead induction training for statisticians and SAS programmers.
• Prepare for and attend audits pertinent to Statistics.
• Participate in audits follow up.
• Provide input to SOPs and QA documents for Biostatistics activities.
• Lead SAS programmers and/or statisticians at project level.

Skills

Statistical analysis

Clinical trial statistics

SAS programming

CDISC ADaM

Adaptive designs

Sample size calculation

Regulatory knowledge

Data interpretation

Communication skills

Education

MSc in Statistics

Tools

SAS software

CDISC ADaM tools

Job description

Company Description

We are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

You will contribute to statistical activities related to global clinical trials and work closely with international teams of statisticians, programmers and data managers, including the role of biostatistics project lead.

In this role, you will:

• Act as a communication line for project teams, clients, vendors and internal team on statistical questions
• Conduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis
• Develop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM standard and other project-specific documents
• Review statistical deliverables such as tables, figures, listings and analysis datasets
• Conduct departmental induction course and project-specific training for statisticians and SAS programmers
• Prepare for and attend internal and external study audits pertinent to Statistics
• Participate in preparation of internal/external audits follow up
• Provide input to standard operating procedures and other Quality Systems Documents (QSDs) pertinent to activities of Biostatistics department
• Liaise with DM on statistical questions related to data issues
• Participate in bid defense and in kick-off meetings
• Lead teams of SAS programmers and/or statisticians on the project level

Qualifications

• MSc in Statistics or equivalent
• Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research
• Expert knowledge and understanding of the SAS programming
• Expert knowledge and understanding of CDISC ADaM standard
• Expert knowledge and understanding of adaptive designs
• Expert knowledge and understanding of sample size calculation
• Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
• Ability to apply advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information
• Ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies
• Strong presentation and communication skills

Additional Information

Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors. Our recruitment process is easy and straightforward, and we'll be there with you every step of the way.