Senior Statistician

About this role

In this role, you will:

Lead all biostatistics activities related to clinical trials as responsible project statistician

Communicate with project teams, clients and vendors on statistical questions

Develop and review statistical sections of protocols, including sample size calculations

Develop statistical analysis plans

Develop and document analysis database structures (i.e. SAS analysis data set structures)

Develop SAS program requirements and specifications

SAS programming and program validation

Review and QC of statistical deliverables (tables, listings, figures, etc.)

Perform statistical analysis and report results

Consult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products

Liaise with DM on statistical questions related to data issues, including coordination of data transfers from DM to Statistics

Participate in bid defense meetings and kick-off meetings

Train statisticians and SAS programmers

Prepare and deliver presentations at investigators' meetings

Address audits findings/recommendations, and follow-up on and resolution of audit findings

MSc in Statistics or equivalent

Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research

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

Expert knowledge and understanding of the SAS programming

Expert knowledge and understanding of CDISC ADaM standard

Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH)

Ability to work in English

Please submit your CV in English.
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.
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.
Originally posted on Himalayas