📍 Location: Any of the Company’s offices in Europe
We are open to receiving applications no matter your current location as the position can be based in any of the Company’s offices in Europe.
Who we are?
Optimapharm is a leading, mid– sized, full– service CRO working across Europe and North America to deliver new therapies to improve and save patients’ lives. Optimapharm’s key priorities are our people and consistently exceeding our client’s expectations.
With 27 strategically located offices, Optimapharm operates in 40+ countries, giving unrivaled access to Patients and Investigators in all countries in Europe and North America.
In– depth expertise and long– standing experience, combined with a flexible and collaborative approach, allow optimization of design and planning; through its strong track record of delivery excellence and committed and stable project teams, Optimapharm has secured a high level of repeat business over the years.
We are looking for a (Senior) Statistical Programmer to join our Data Management and Biostatistics team and support us in making a tangible difference to project sponsors and benefiting patients and their families all around the world.
What do we offer?
- Working in a successful company that’s growing and changing every day
- Working with a highly experienced team of the clinical research professionals
- International projects and professional growth
- Performance bonus
- Training opportunities
- Work from home
- Flexible work hours
Who are we looking for?
Qualifications And Experience
- BS or higher degree in Biostatistics, Mathematics, or related fields. Or a combination of education, training, and work experience
- Experience in CDISC (ODM/SDTM/ADaM)
- Strong analytic mindset and logical thinking capability
- Computer and arithmetic knowledge, as well as skills to adapt to different computer systems
- Advanced SAS programming and other statistical software
- Excellent written and oral English communication skills
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Ability to communicate effectively with appropriate internal and external contacts
- Ability to work on multiple projects and to manage project timelines
- Good organizational and time management skills and initiative
- Good communication and presentation skills
- Good people skills and team player
Your responsibilities
- Primarily working with the Data Managers, Statisticians and Clinical Project Managers on ongoing clinical studies to assure results are consistent with expectations, and Quality control procedures are followed
- Participating in the creation and review of key statistical documents includingbut not exclusive to:
- Case Report Form
- Data Specifications
- Data Transfer Agreements
- Statistical Analysis Plan
- Tables, Listings and Figures Shells
- Creation of statistical outputs, with the support of Statisticians, according to specifications including but not exclusive to:
- Datasets (e.g., raw, SDTM, ADaM datasets)
- Randomization Lists
- Tables
- Figures
- Listings
- Liaising with Statisticians and Data Management and Biostatistics Managers at regular intervals to discuss progress and any issues outstanding
- Liaising and collaborating with corresponding teams in other departments working on the same project
- Training other project team members to make full and correct use of the company Data Capture systems, when used, for the collection of clinical data
- Producing information/reports directly from the clinical database or via the appropriate procedure to request a new report from the appropriate department or vendor
- Liaising with personnel at the sponsor company, or their designates, with Central Event Adjudication Committees, Data Safety Monitoring Committees or any other third parties involved in statistical programming activities
- Participating as necessary in qualifications or audits performed to vendors which provide services related to statistical programming activities
- Participating as necessary in sponsor audits, regulatory authority inspections and other third– party meetings. Ensure that any recommendations are discussed and that solutions are incorporated
- Developing and maintaining relevant report metrics to share with the overall study team and upper management
- Supporting other departments with additional ad– hoc tasks such as preparation of reports, listings, statistical analysis, etc.
- Applying company standards, and actively participating in improvements towards harmonization and standardization across projects. In particular, participate in the creation and maintenance of programming standards
- Maintaining and expanding knowledge base in the area of expertise. Attends courses to develop and keep skills and knowledge current. To comply with continuing education requirements.
- Working together with the study team including the biostatistician, data manager and medical writer
By joining our fast– growing and prosperous team, you will have a great opportunity for further personal growth and career development.
If you are interested in joining the Optimapharm team, please send your CV in English and note that only shortlisted candidates who meet the requirements will be contacted for further selection.
