Unit: Biometric Unit (Biostatisticians & Data Managers)
Contract type: Full-time 
Direct report: Chief Executive Officer

Summary:

The Head of Biometrics is responsible for creating and implementing the strategic direction for biostatistics & data management in all phases of development (both on pharma, medical devices, IVD and food supplement) and ensuring that proper statistical analyses and data management and interpretations are carried out.  S/he will be responsible for developing functional infrastructure and in building the biometrics capabilities in-line with the broader development strategy.  The Head of Biometrics will be a key contributor to the long-term planning for the development organization and directly accountable for key milestone that support corporate objectives and business strategies.

Main duties and responsibilities:

•    Serve as a strategic partner working closely with clinical development and other relevant company units in providing statistical input to clinical development plans and trial designs
•    Provides support in working with regulatory submissions, responses to regulatory authority questions, and preparation for regulatory authority meetings (e.g., advisory panels or other meetings)
•    Presents analyses to internal and external audiences (e.g. regulatory agencies, collaborators, investigators, vendors, etc.)
•    Responsible for the development of statistical analysis plans/reports/models, to include statistical methodology (including authoring), statistical programming procedures, and production of tables, listings and figures
•    Provides expert statistical review/QC and input into statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, and statistical sections for integrated reports) and data management deliverables (i.e. database design, critical data checks and validation)
•    Provides input on relevant sections of research protocols and regulatory documents including endpoint specification, study logistics, sample size determination/justification, randomization plans, interim analyses, stopping rules (if applicable)
•    Oversees the operations and procedures for the collection, editing, verification and management of data
•    Manages data release and review for clinical projects; reviews and participates in QC and finalization of various documents, including abstracts, posters, manuscripts, publications, press releases, study reports, regulatory documents, etc.
•    Collaborates with partner functions to provide statistical programming, systems analysis and database management support for observational studies/projects using internal observational health related database resources
•    Oversees and supports the Biometrics team, ensuring their performance aligns with functional expectations, quality standards, and strategic direction
•    Leads Clinical Data Management, Data Programming, Statistical Programming, and Biostatistics services
•    Coordinates and supervises the study eCRF design and validation process and eCRF Guidelines preparation
•    Coordinates and supervises data management activities related on CRF model/patient diaries preparation, Data Management Plan and Data Management Report, cleaning activities, queries and protocol deviations management
•    Leads the development, review, and continuous refinement of Standard Operating Procedures (SOPs), Work Instructions (WIs), and associated forms/templates that align with company standards and regulatory expectations within clinical research
•    Participates in Sponsor or vendor audits as assigned 
•    Participates in Sponsor or vendor meeting and bid defense meeting
•    Participates in the documentation and implementation of Company corrective and preventative actions (CAPA) plans upon request
•    Trains new staff, fosters inclusion and a cohesive working environment, and develops staff through coaching/mentorship
•    Maintains up-to-date knowledge of clinical research industry standards and trends to ensure continuous alignment with global best practices. 
•    Mentors and supports Biometrics personnel in executing process improvement initiatives, providing hands-on coaching and support to foster professional development. 

Education and experience:

•    Master or PhD in statistics or related field
•    15+ years of experience in pharmaceutical and/or CRO, biotech, medical device industry or equivalent (global experience strongly preferred)
•    Experience with regulatory agencies
•    Expert knowledge of Good Clinical Practice and FDA regulations/guidelines for clinical research, ICH and ISO 14155.

Technical skills:

•    Familiarity with Microsoft Office tools (Excel, Word, etc.)
•    Familiarity with the main EDC systems and the design and validation processes of electronic CRFs
•    Very good knowledge of SAS
•    Excellent knowledge of written and oral English 
•    Knowledge of software for calculating sample sizes (PASS, nQuery, etc.)
•    Preferable knowledge of CDISC standards (SDTM, ADaM, CDASH).

Soft skills:

•    Prior people management experience and experience identifying organizational needs (talent, process, technology) is required
•    Strong interpersonal and communication skills with the ability to influence stakeholders and collaborate effectively with functional heads
•    Commitment to quality, compliance, and continuous improvement
•    Excellent organizational, problem-solving, teamworking, and decision-making skills in a dynamic environment
•    Excellent written communication skills, including competent grammatical/technical writing ability
•    Excellent oral/interpersonal communication skills, including public speaking/presenting ability.

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Location: Full-remote
Contract type: Full-time 

Tasks and responsibilities:

•    Collaborate with the Head of Regulatory Affairs in the:
•    Preparation, review, and submission of regulatory and Technical Documentation for CE-marking of medical devices, ensuring full compliance with EU MDR (2017/745) and other applicable regulations;
•    Drafting of scientific/regulatory documents, including but not limited to classification and mechanism of action rationales, BEP/BER according to ISO 10993-1, ADME evaluations, Risk Management according to ISO 14971, CEP/CER;
•    Support in post-market surveillance activities: PMS, PMCF, PSUR;
•    Support in registration, submission, document presentation and communications with Notified Bodies and/or Competent Authorities;
•    Definition and implementation of documentation and processes inherent to a Quality System in compliance to the ISO 13485;
•    Preparation and conduction of regulatory and quality training.

Minimum Requirements:

•    Degree in scientific field 
•    At least 3-5 years of experience in medical devices regulatory affairs management
•    Advanced English knowledge

Nice to have:

•    Experience in IVD and food supplement/novel food
•    Experience in clinical investigation management
•    Experience in FDA submission and FDA 510K 

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Location: Full-remote
Contract type: Full-time 

Job Overview:

PRINEOS is looking for a Data Management Coordinator to manage, coordinate, and organize the activities of the Data Management staff. The candidate will collaborate with cross-functional teams, including Clinical Operations, Biostatisticians, Medical Affairs, and Project Managers. The candidate should have excellent knowledge of regulations and reference standards, as well as on major medical dictionaries such as MedDRA, WHO-DD, etc.

Key Responsibilities:

•    Manage, coordinate, and supervise data management activities on clinical studies and investigations (drugs, nutraceuticals, medical devices, IVDs, etc.);
•    Coordinate and supervise the design, configuration, and maintenance of clinical databases and electronic CRF;
•    Coordinate and supervise the drafting and review of data management documentation (e.g., Data Management Plan, Data Validation Plan);
•    Coordinate and supervise data cleaning and query management activities in compliance with study timelines and quality standards;
•    Coordinate and supervise clinical data review and reconciliation activities to ensure data integrity;
•    Coordinate and supervise the design and validation of study eCRFs;
•    Follow the coding process for adverse events (AEs), medical history terms, and concomitant medications; 
•    Coordinate and supervise database closure and data transfer activities;
•    Supervise and coordinate activities delegated to external CRF service providers;
•    Maintain documentation in compliance with GCP, company procedures, and applicable regulatory requirements;
•    Interact with clients, auditors, and competent authorities for the Data Management Unit's activities;
•    Collaborate with the Business Development Unit in preparing proposals;
•    Participate in client meetings (bid defense, kickoff, etc.) and ensure continuative and proactive collaboration with other business units.

Minimum Requirements:

•    Scientific degree is preferred (e.g., Biology, Biotechnology, Pharmacy, Statistics, Biomedical Engineering);
•    10 years of experience as Data Manager; 
•    Familiarity with Microsoft Office tools (Excel, Word, etc.);
•    Familiarity with the main EDC systems and the design and validation processes of electronic CRFs;
•    Strong attention to detail and organizational skills;
•    Excellent written and spoken English.

Preferred Requirements:

•    Previous experience in resource management and team coordination;
•    Knowledge of SAS programming.

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Line Manager: Biostatistics Coordinator

Main tasks and responsibilities:

•    Contribute to the design of clinical trials by providing an appropriate statistical methodology
•    Participate in the definition of study protocols, concept sheets and abstract
•    Perform sample size calculation
•    Prepare the Statistical Analysis Plan (SAP)
•    Perform statistical analysis
•    Review study objectives and endpoints with the team
•    Prepare statistical reports and CSR statistical sections 
•    Generate and manage randomization lists 

Minimum Requirements:

•    At least 2 years of experience as Biostatistician (preferable in a CRO)
•    Scientific degree in Statistics
•    SAS programming
•    Good English written and spoken

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Main tasks and responsibilities (in cooperation with the Head of Quality Management)

•    Maintain GCP/ICH and ISO 9001 compliant systems and processes which control the quality of work and clinical trials conducted 
•    Write and/or review clinical SOPs and support continuous process improvements
•    Manage training of staff on company procedures, GCP regulations, and documentation systems
•    Manage induction training for new employees and for scientific consultants
•    Qualify critical vendors
•    Perform documentation control in the TMF and quality reviews of clinical trial essential documents and associated documentation (including Protocols, Investigator’s Brochure, CRFs, etc.) as appropriate
•    Perform routine internal System and TMF audits and checks throughout the lifecycle of a trial/program to ensure compliance with internal procedures, as well as regulatory guidelines
•    Report significant clinical quality deficiencies and/or risks to upper management and actively participate in solving the issues
•    Perform clinical site GCP auditing activities to ensure that studies are conducted in accordance with protocols, GCP and other applicable regulation
•    Participate in Sponsor Audit and Competent Authorities Inspections
 

Minimum requirements:

•    Scientific Degree (ideally Master/ PhD in Biology, Biotechnology, Life Sciences, etc.)
•    At least 3 years of experience in Clinical Quality maintenance and oversight 
•    A high level of English language, both written and spoken
•    Excellent interpersonal skills, ability to work in teams, flexibility in changing tasks and priorities and motivation for new challenges
•    Preferred: qualified Auditor according to Italian Decree on CRO Minimum Requirements (15.11.2011)

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