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.
- 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 email@example.com