Clinical Biostatistician

Location Global , Netherlands
Discipline: Pharmaceutical
Job type: Permanent
Contact name: Ivor Duif

Contact email: i.duif@panda-int.com
Job ref: 10990
Published: 16 days ago

For one of our big pharma clients we are looking for a Clinical Biostatistican! This is a full remote position, two year contract.

Within this role you will be responsible for designing statistical analysis plans for clinical studies; performing statistical analyses; contributing to reports and supporting statistical analytical services in support of clinical trials, regulatory submissions, marketing efforts, quality initiatives, and internal presentations.  His/her work will follow guidance from Biostatistics management, and will adhere to applicable regulations for pre- and post market clinical trials. S/he ensures statistical analyses are conducted with the highest level of scientific integrity, while meeting timelines and budgets.

Reporting to the Biostatistics Manager.

POSITION DUTIES & RESPONSIBILITIES:

-  Analyze and report on clinical trials according to industry standards, generation Statistical Analysis plan, TFL templates, TFL validation programming, programming the statistical analysis. 

-  Interact with Biostatistics, Data Management, Regulatory, and Clinical staff to define and clarify project requirements.

-  Design and execute statistical plans for all phases of clinical studies  of limited complexity, and under limited supervision.

-  Review clinical study protocols and Case Report Forms (CRFs) for proposed studies with respect to statistical methodology.

-  Generate randomization schemes; unblind treatment assignments and handle unblinded information appropriately.

-  Support the review and assessment of protocol deviations to the extent that they affect statistical analyses.

-  Produce statistical reports that may be incorporated into internal clinical reports or regulatory submissions.

-  Contribute to peer-reviewed articles under supervision.

-  Review articles on topics relevant to specified products and provide reports concerning issues relating to statistical methodology.

-  Assist with preparation of documentation for IRB/Ethics Committee submissions (e.g., statistical power analysis).

-  Assist in the preparation and documentation of  results to support trial reports and publications.

-  Provide statistical reports for data quality/performance metrics.

-  Assist Clinical Research with literature reviews and other activities if required by biostatistics leadership.

-  May assist in summarizing information to be used for presentations at professional meetings.

-  Stay current with statistical methodology in clinical trial design and analysis.

 

Functional and Technical Competencies:

 

-  Demonstrated technical experience in preparing statistical deliverables on time.

-  Thorough understanding of descriptive statistics, hypothesis testing, non-parametric, and multivariate statistical tests.

-  Experience with survival analysis, longitudinal data analysis, and other current, innovative statistical methodologies.

-  Excellent verbal and written communication skills.

-  Knowledge of Microsoft packages; PowerPoint, Excel, Word.

-  Proficient in SAS. Familiarity with other statistical packages for handling smaller datasets and power analyses.

 

Leadership Competencies:
-         Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

-        Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.

-        Performs other related duties as required.

-         Strong leadership required in alignment with J&J Leadership Imperatives: Connect, Shape, Lead, Deliver  as noted below.

-  Connect  - Manage multiple objectives from diverse stakeholders

-  Shape – Develop knowledge of therapeutic areas within the Franchises and translate key insights into evidence claims or product differentiators

-  Lead – Make decisions regarding the selection of statistical tests to be performed and how to present data.

-  Deliver – Ensure statistical deliverables are produced on time, within budget and in compliance with regulations and SOPs

EDUCATION & EXPERIENCE REQUIREMENTS: 

-  A Master’s degree or Ph.D in Statistics.

-  At least 2 years of experience (or Ph.D. with 0 to 2 years) performing statistical analyses in a regulated environment, preferably medically related including FDA, GCP or other relevant area.

If interested to know more please get in contact with Ivor Duif (Recruitment Consultant) via +3120 20 44 502 or i.duif@panda-int.com