Senior Statistician

JobsInSAS.com; Durham (NC); On-site; USD 110,000 - 165,000; Full time

Job summary

PSI CRO in Durham, North Carolina, seeks a Senior Statistician to contribute to global clinical trials, collaborating with statisticians, programmers and data managers, and potentially lead biostatistics projects.

You will perform statistical analyses, develop SAPs, review datasets, support audits, and lead teams of SAS programmers on project level.

Qualifications

• MSc in Statistics or equivalent.
• Expert knowledge of statistical principles used in clinical research.
• Expert knowledge of SAS programming.
• Expert knowledge of CDISC ADaM standard.
• Experience with adaptive designs and sample size calculations.
• Familiarity with FDA/EMA/ICH guidelines.
• Ability to interpret complex statistical information and communicate it clearly.
• 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 and final analyses, PK analyses, and DSMB/DMC support.
• Develop and review study protocols, SAPs and analysis datasets.
• Review statistical deliverables such as tables, figures and listings.
• Lead and mentor SAS programmers and statisticians at the project level.
• Prepare for and participate in audits and quality system processes.
• Contribute to standard operating procedures within Biostatistics.

Skills

Statistical analysis

SAS programming

CDISC ADaM

Adaptive designs

Sample size calculation

Regulatory knowledge

Data interpretation

Communication

Education

MSc in Statistics or equivalent

Tools

SAS

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 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Senior Statistician

PSI CRO

• Full-time
• Durham, North Carolina, United States
• 6d ago

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.

PSI CRO