Principal Statistician (Pharmacokinetics)

Psi CRO Ag; Durham (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

Psi CRO Ag in Durham, North Carolina is seeking a Biostatistics Project Lead to contribute to statistical activities in global clinical trials. You will act as a liaison for project teams and conduct various statistical analyses while ensuring compliance with regulatory standards.

The ideal candidate has an MSc in Statistics, expert SAS programming skills, and significant experience in clinical research statistics. This position is full-time and offers opportunities for professional development within a dynamic global firm.

Qualifications

• Full working proficiency in English.
• Ability to apply advanced statistical techniques in clinical research studies.
• Expert knowledge of regulations and guidelines (e.g., FDA, EMA, ICH).

Responsibilities

• Act as a communication line for project teams on statistical questions.
• Conduct statistical analysis for clinical trials and interim analysis.
• Develop and review statistical analysis plans and study protocols.

Skills

SAS programming

Statistical analysis

Statistical principles

CDISC ADaM standard

Pharmacokinetics principles

Presentation and communication skills

Education

MSc in Statistics or equivalent

Tools

Phoenix WinNonlin

Job description

• Full-time

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
• 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
• Full working proficiency in English
• 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 pharmacokinetics principles, concepts, methods and standards used in clinical research, including the conduct NCL and population PK analysis
• Expert knowledge and understanding of Phoenix WinNonlin and NLME
• Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH)
• Ability to apply a range of 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.