Safety Statistical Programmer
Remote
United Kingdom
Freelance
27-02-2025
Job Specifications
Safety Statistical Programmer
12 months
Remote
Inside IR35
Key Skills: safety data standards, SAS programming, Familiarity with pharmacovigilance data sources
The primary purpose of the position is to act independently and contribute to the creation and delivery of safety analyses and reports, primarily based on Asset-Level Safety Analysis Plans (ALSAPs) to support pharmacovigilance activities. This role involves close collaboration with safety statisticians, epidemiologists, and other stakeholders to ensure accurate and timely delivery of safety data for review by Safety Assessment Committees (SACs) and Safety Management Teams (SMTs). The programmer will also be responsible for generating background rates for anticipated adverse events to support contextual safety assessments. This position requires a strong understanding of statistical programming principles, clinical trial and observational data, safety databases, and regulatory guidelines related to safety reporting.
Responsibilities and Accountabilities:
• Contribute to the implementation of ALSAPs by programming the required analyses and ensuring alignment with the overall safety strategy for assigned compounds; responsible for the high-quality, on-time development and execution of statistical analysis and reporting deliverables (e.g., safety analysis datasets SDTM/ADAMs, tables, listings, figures (TLF)).
• Is a key collaborator with safety statistics in ensuring that specifications for safety analyses are complete and statistical plans are executed efficiently with the right level of validation.
• Provide programming support for SAC and SMT meetings, including the timely generation of ad-hoc analyses and TLFs as needed. This may involve unblinded data access when required and authorized.
• Computes background rates from various sources for key adverse events of safety interest and implement statistical methods for safety monitoring in blinded clinical trials.
• Enforces, industry and regulatory standards in programmed deliverables (including CDISC standards for datasets and internal TLF standards) so that deliverables are ready to be used in regulatory submissions.
Personal development / Collaboration
• Actively participates in the development and implementation of programming tools for Statistical Programming infrastructure projects.
• Is responsible to efficiently communicate, at regular intervals, to Safety Statistician and/or line management on study/project/initiative status and resource issues.
Required Qualifications:
• Bachelor’s or master’s in statistics, mathematics, or related field
• 6+ years (9+ years for Bachelor) of experience of relevant programming experience in the pharmaceutical industry
• 2+ years’ 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.
If you are interested please apply or send your CV to luke.sandilands@cpl.com
About the Company
At Cpl UK Life Sciences, we're experts at connecting talented professionals with the most ambitious companies in the industry. With excellent local knowledge of markets across the UK, Switzerland, and the USA, you can trust us to help with all your life science recruitment. We cover: - UK - Switzerland + Europe - USA From big pharma, CROs to small biotech start ups, we can deliver the total talent solutions you need. - Permanent - Contract/temporary - FSP - Embedded (multi-hire) -Executive Search Our team has an acut... Know more
Related Jobs
- Company Name
- Skillsbay
- Job Title
- Software Developer - React/PHP
- Job Description
- Software Developer - React/PHP Remote 3 months initially (possibility to extend to 18 months) Outside IR35 Role Requirement Essential skills, knowledge, and behaviours: A collaborative way of working with product managers, other developers Must adhere to client development standards and processes Significant and demonstrable experience of designing and developing the Front End for enterprise-scale web applications. Able to create code that is both high quality and easily maintainable. Able to work closely with the existing team to contribute to decisions about technology choice, technical design, and approach. Ability to introduce software development process improvements where necessary, including transitioning the team to working with infrastructure as code (eg Terraform). Fluency with the React, PHP 7, Docker, Terraform Ideally knowledge of Symphony 4, Typescript, MySQL Familiarity of integrating with REST-based APIs Knowledge of how to develop secure applications. Good verbal and written English-language skills. Desirable skills, knowledge, and behaviours: Working with Cloud platforms, preferably AWS. Security-related requirements: All developers must have had their identification verified and any prior criminal record fully assessed to reduce security risk. All employees must have completed security awareness training, covering common attacks on users, such as phishing and other means of enticing users to disclose sensitive information, or download unauthorised code. There must be a positive security culture where employees actively report suspected or actual incidents promptly in a no-blame environment. Candidates must be eligible to work in the UK without Visa restrictions. Candidates must submit a CV for consideration.
- Company Name
- Initialize
- Job Title
- UI ExtJS Developer
- Job Description
- UI ExtJS Developer - Glasgow - 6 months - £318 Design and develop complex user interfaces using ExtJS version 6 or beyond, ensuring high performance and responsiveness. Implement and maintain the MVVM and MVC paradigms to create scalable and maintainable codebases. Develop and maintain generic components to promote code reusability and efficiency. Debug and troubleshoot applications in test and production environments, providing timely and effective solutions. Apply SCSS/SASS frameworks to enhance the styling and design of user interfaces.
- Company Name
- Damia Group LTD
- Job Title
- Frontend Developer
- Job Description
- Frontend Developer - Remote - £500-£600 per day (OUTSIDE IR35) - 8 weeks All applicants must hold an active SC clearance. My client is a global IT consultancy. They are on the hunt for a Frontend Developer to join a central government client of theirs on an initial 8 week role. You will not be building during this discovery, you will just need to be able to access theirGithub repo and herokuand complete some Power BI work. Your main activities will involve coming up with possible solutions to the requirements they have and any emerging ones discovered during the UR Frontend Developer - Remote - £500-£600 per day (OUTSIDE IR35) - 8 weeks Damia Group Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept our Data Protection Policy which can be found on our website. Please note that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and ability to perform the duties of the job. Damia Group is acting as an Employment Business in relation to this vacancy and in accordance to Conduct Regulations 2003.
- Company Name
- Harvey Nash
- Job Title
- Oracle Integration Cloud (OIC) Developer
- Job Description
- Job Title: Oracle OIC Developer Location: Reading or Havant or Thatcham Mode of working: Hybrid (3 Days in the Office) Duration: 6+ Months contract. Job Spec: Role Description: We are seeking a highly skilled Oracle Integration Cloud (OIC) Developer to join the client - Oracle HCM Cloud Programme. The ideal candidate will have direct experience in designing, developing, and implementing integrations using Oracle Integration Cloud to connect cloud and on-premises applications. As an OIC Developer, you will play a key role in enabling seamless communication between Oracle HCM, Oracle EBS, and third-party applications, ensuring that data flows efficiently, accurately, and securely. Top Skills: 3+ years of direct experience in developing and implementing integrations using Oracle Integration Cloud (OIC). Experience with integrating Oracle Cloud applications (such as HCM, EBS, ERP, SCM). Prior experience in cloud-to-cloud and cloud-to-on-premises integrations. Key Skills: Demonstrable knowledge of Oracle Integration Cloud (OIC) to implement integration flows, creation of custom logic and exception handling. Proven experience in connecting and synchronising Oracle Field Service with Oracle HCM modules, including Core HR, Time and Labour and Workforce Scheduling. Preferred experience in connecting Oracle HCM Payroll with third party applications eg HMRC. Proficient in using Oracle Adapters (eg, Oracle EBS Adapter, Oracle HCM Cloud Adapter) for integration purposes. Proficient in using SOAP, REST APIs, and web services for connecting and integrating third-party systems through custom integrations. Expertise in data transformations and mapping between different data formats and systems. Good understanding of Oracle SOA Suite, Oracle Service Bus (OSB), or similar integration tools. Experience with SQL, PL/SQL, and database integration for working with relational data stores.