Sas Statistical Programmer
hace 1 mes
**Location: 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 including**but 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.
- 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.
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