Principal Biostatistician (Germany)

Description The Principal Biostatistician will act as Lead Biostatistician on multiple phase 1 to 4 clinical trials and/or Biostatistical Oversight for programs of phase 1 to 4 clinical trials, providing input into the statistical sections of protocols (incl. sample size calculation/ validation), Risk-based Monitoring Plans, various Data Management (DM) documents, and statistical sections of clinical study reports (CSRs). The Principal Biostatistician will also ensure the general financial health of clinical trials, develop Statistical Analysis Plans (SAP; incl. Table, Listing, and Figure [TLF] shells), support teams of Statistical Programmers performing statistical analysis of clinical trial data, perform peer-review of biostatistical deliverables, and act as Unblinded Biostatistician for Randomization List and Interim Analyses (IAs). The Principal Biostatistician will work collaboratively within Biostatistics study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and guidelines, and Indero’ standard operating procedures (SOPs) and processes. The Principal Biostatistician will also lead internal initiatives to increase efficiency/quality of Biostatistics activities/deliverables, act as Subject Matter Expert (SME) and coach for at least one Biostatistics-related topic, and development/maintain (new) trainings provided to Biostatisticians and/or Statistical Programmers.

More specifically, the Principal Biostatistician will:

Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time.

Act as Lead Biostatistician, with minimal support, on multiple Phase 1 to 4 clinical trials by:

• Acting as Biostatistics primary point of contact for Leads from other Indero departments, Sponsors, and 3rd party vendors for clinical trials.
• Be responsible for all statistical aspects of clinical trials.
• Supporting teams of Statistical Programmers performing statistical analyses of clinical trials data.
• Managing timelines of Biostatistics study team deliverables for clinical trials.
• Reviewing the scope of work and budget for Biostatistics study teams at initiation of clinical trials.

Proactively and promptly identifying out of scope (OoS) works throughout the course of clinical trials, providing Project Managers with budget estimate, and making sure that these OoS budgets are properly included in Change Orders (COs). Ensuring that the forecast of Biostatistics study teams’ budget is accurate at all times, performing revenue recognition of Biostatistics budgets on a monthly basis, and monitoring monthly, project-to-date, and overall HPIs of clinical trials.

Review and provide input into statistical sections of protocols (incl., sample size calculations or validation) to ensure statistical designs and planned statistical analyses clearly and robustly address the objectives of clinical trials and program of studies. Participate to the development of Risk-based Monitoring Plan for clinical trials by ensuring that appropriate critical data are taken into consideration when developing this plan and appropriate monitoring strategy are selected for each of these critical data. Review and provide input into various DM documents (e.g., electronic Case Report Forms [eCRF], Data Validation Specifications [DVS], Data Transfer Agreements [DTAs], etc.) for clinical trials and support DM with data cleaning activities by programming, reporting, reviewing, and closing biostatistical data issues in collaboration with Statistical Programmers. Develop/Perform peer-review of Unblinding Plans, SAPs, and TLF Shells for clinical trials. Perform Lead Biostatistician review or peer-review of Clinical Data Interchange Standards Consortium (CDISC) Standard Data Tabulation Model (SDTM) trial domains, subsets of Analysis Data Model (ADaM) datasets (e.g., ADSL, efficacy, ADaMs with complex derivations, etc.) or derived datasets (as applicable), and all TLFs of clinical trials based on the protocol, SAP, TLF Shells, and Innovaderm and/or Sponsor' standards and interpretation of CDISC SDTM Implementation Guideline (IG), ADAM IG, and Controlled Terminology (CT). Review and provide input into statistical sections of CSRs to ensure results from statistical analyses are correctly reported and interpreted. Act as Unblinded Biostatistician by developing or reviewing Randomization Plans, Dummy Randomization Lists, and Final Randomization Lists for clinical trials as well as by leading Unblinded Biostatistics teams and supporting Independent Data Monitoring Committees (IDMCs) for IAs.

Act as Biostatistical Oversight for programs of Phase 1 to 4 clinical trials by:

• Ensuring consistency of statistical methodologies and statistical programming techniques across studies.
• Representing the Biostatistics function (incl. Statistical Programming) on Partnership Committees.
• Take on key statistical responsibilities in the planning and preparation of regulatory submission.
• Conduct statistical analysis for Investigator Initiated Studies (IISs) and internal research and development (R&D) projects.
• Contribute to the identification of/Lead internal initiatives to increase efficiency/quality of Biostatistics activities/deliverables.
• Keep oneself abreast with latest Industry and CDISC standards as well as ICH and Regulatory Authority guidance and requirements.
• Act as SME and coach for at least one Biostatistics-related topic, including innovative study designs and novel statistical methodologies.

Development, maintain, and/or review trainings provided to Biostatisticians and/or Statistical Programmers, ensuring trainings are in line with latest ICH Guidelines, Regulatory Authority requirements, and Indero’ standards and processes.

• Review and provide input into new/revised SOPs related to Biostatistics and/or Statistical Programming activities.

May also:

• Contribute to the development/maintenance/validation of the statistical programming of ADAMs and TFLs for clinical trials.
• Advise strategically (through innovative ideas or applications) on the design of valid, efficient, and cost-effective clinical trials, IISs, and internal R&D projects.
• Review clinical trial results, accurately interpreting and clearly communicating statistical concepts and results to non-statisticians, and provide valuable insights driving decision-making.

Interact with regulatory agencies and support Sponsors with NDAs, including ensure documentation, statistical results, and study datasets meet the regulatory agency’s requirement/expectations (e.g., CDISC) and respond to regulatory agency queries.

• Attend meetings outside of employees’ normal business hours.
• Employee may be assigned to other responsibilities that do not pertain to the former description, if they have the required experience, are qualified and/or have received adequate training.

Requirements IDEAL PROFILE Education

• Master’s degree or PhD in Statistics, Biostatistics, or a related field with some applied biostatistics training relevant to clinical trials required.

Experience At least 10 years of clinical trials experience in the Biotechnology, Pharmaceutical, and/or Contract Research Organization (CRO) industries required, including at least 7 years acting as Lead Biostatistician for phase 1 to 4 clinical trials.

• Knowledge and skills

Excellent knowledge of drug development process, ICH guideline (including but not limited to, ICH E6(R2), E9, and E9(R1)), and relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations and guidelines required.

• Extensive exposure to clinical trial data, SAPs, and TLF Shells required.
• Excellent knowledge of CDISC standards and guidelines required.

Advanced working knowledge of SAS for the purpose of analyzing clinical trial data required. Experience leading internal initiatives to improve efficiency/quality an asset. Very organized and detail-oriented, with effective project planning and time management skills. Ability to work in high-speed environment with proven agility to juggle and prioritize multiple competitive demands. Must be able to work independently and as part of a team. Strong verbal and written communication skills in English; French an asset

Our company The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

Flexible work schedule / work schedule Home-based position Ongoing learning and development About Indero Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Germany.

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