AddressLocation: 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 Senior Statistical Programmerto join our team anywhere in Indiaand 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
- 5-9 years of experience as a Statistical Programmer in CROs, pharmaceutical companies, biotech companies, or similar
- Knowledge of GCP and ICH Guidelines
- Experience in business development activities, supporting sales teams in the preparation of proposals, and bid defenses
- Experience in the implementation of technologies and process automatization within CROs, pharmaceutical companies, biotech companies, or similar
- Experience in the implementation of quality systems
- SAS Certified Specialist: Base Programming Using SAS
- SAS Certified Professional: Advanced Programming Using SAS
- 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
- CDISC Mapping Documentation
- Liaising with Statisticians and Data Management and Biostatistics Managers at regular intervals to discuss progress and any issues outstanding
- 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
- Deriving and adapting data for analysis, producing patient listings, summary tables, figures and patient profiles, as part of SAS Programming
- Producing or participating in the validation of SDTM Domains based on the provided Specifications, including Pinnacle 21 execution, producing or reviewing SDTM Specifications, SDTM reviewer guides, Define.XML, and any other documentation required for SDTM derivation, producing or participating in the validation of ADaM Datasets based on the provided Specifications, including Pinnacle 21 execution, producing or reviewing ADaM Specifications, producing ADaM Reviewer guides, Define.XML, and any other documentation required for ADaM derivation, as part of CDISC Mapping
- Training other project team members to make full and correct use of the company procedures and Biostatistics Reporting Environment
- Applying company standards, and actively participating in improvements towards harmonization and standardization across projects
- Participating as necessary in sponsor audits, regulatory authority inspections, and other third-party meetings
- Performing necessary administrative functions
- Entering and updating 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.
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.
