Junior Statistical Programmer

6 months ago

Bengaluru Karnataka, India Optimapharm d.o.o. Full time

**Location: home-based**

***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 **Junior** Statistical Programmer** **to join our team **anywhere** **in **India** **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
- Competitive salary and 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
- ** It will be considered an advantage if you have up to 2 (or more) years of e**xperience** as a Statistical Programmer in CROs, pharmaceutical companies, biotech companies, or similar
- Knowledge of **GCP **and **ICH Guidelines **is a plus
- Strong **analytic mindset and logical thinking capability**:

- ** Computer and arithmetic knowledge**, as well as skills to adapt to different computer systems
- Good **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**:
Working alongside your experienced colleagues, you be participating in and learning how to:

- Primarily work 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**:

- Participate 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
- CDISC Mapping Documentation
- Liaise with Statisticians and Data Management and Biostatistics Managers at regular intervals to discuss progress and any issues outstanding
- Derive and adapt data for analysis, producing patient listings and summary tables
- Produce or participate in the validation of SDTM Domains based on the provided Specifications, including Pinnacle 21 execution, produce or participate in the validation of ADaM Datasets based on the provided Specifications, including Pinnacle 21 execution
- Participate as necessary in sponsor audits, regulatory authority inspections, and other third-party meetings
- Perform necessary administrative functions
- Enter and update data in relevant CTMS modules

**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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