Offer
- a quality orientated organisation in the pharmaceutical industry
- working in an international environment
- a temporary contract or an independent contract from Derks & Derks Secondment & Interim
- a contract for 12 months with the possibility to extend
Position
As a Safety Statistical Programmer within the pharmacovigilance team, you are responsible for creating and delivering safety analyses and reports, primarily based on Asset-Level Safety Analysis Plans (ALSAPs). You will work closely with Safety Statisticians, Epidemiologists, and other stakeholders to ensure that safety data is delivered accurately and on time for review by Safety Assessment Committees (SACs) and Safety Management Teams (SMTs). You will program the necessary analyses and ensure that they align with the safety strategy for the assigned products, being responsible for delivering statistical analyses and reports, such as safety analysis datasets (SDTM/ADAMs), tables, listings, and figures (TLFs) on time and with high quality.
In addition, you will be responsible for calculating background rates for anticipated adverse events from various data sources and supporting SAC and SMT meetings with ad-hoc analyses and TLFs when needed. You will maintain our clients and regulatory standards for programmed deliverables, ensuring they are ready for regulatory submissions. Furthermore, you will actively contribute to the development and implementation of programming tools for the statistical programming infrastructure of the team. You will regularly and efficiently communicate with the Safety Statistician and/or line management regarding the status of studies, projects, and any resource-related issues.
Profile
- bachelor or master degree in Statistics, Mathematics, or related field
- 6+ years (9+ years for bachelor) of experience of relevant programming experience in the pharmaceutical industry
- 2+ years of experience as a lead programmer for a drug development program
- hands-on experience in supporting SAC and SMT discussions
- strong proficiency in SAS programming (Base SAS, SAS/STAT, SAS Macro) and R for safety data analysis
- experience with safety data standards (MedDRA coding, SMQs, SOC-level analysis, etc)
- familiarity with pharmacovigilance data sources (e.g., FAERS, EudraVigilance) and signal detection methods
- experience in programming statistical methods for safety signal detection
Organisation
The organisation is an international pharmaceutical organisation that has been operating in at least forty countries across Europe, the Middle East and Africa. They operate on a global level and most teams have a global focus. They have everything in house like research, development, manufacturing, warehousing, but also sales and marketing. It is their hope to change tomorrow and to improve the lives of individuals by providing innovative medicines in areas of health where there is an urgent need for better treatments. The organisation is clearly focused on bringing high-quality medicines to the market to reach their goals. At this moment they are open to meet an enthusiastic candidate for a temporary position as Safety Statistical Programmer at their site in Leiden.
Response
Interested? Please send your resume and motivational letter by e-mail, with reference to MSP/25-095, to Annerien Peters: info@derksenderks.nl. For further information, please call, text or Whatsapp Annerien Peeters via +31 (0)6 4540 3933.
Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.
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