Offre d'emploi: principal biostatistician:Randstad.chJob description:
job detailspublié . 17. novembre 2021 lieu . basel, bâle-ville secteur . life sciences type d'emploi . contract référence . 16780 contact . audrey bisch, bâle professionals health care & life sciences téléphone . 058 201 55 50 appliquer > description du posteDo you want to work in a big pharmaceutical company? Do you have experience in clinical trial data analysis? You should then read the following lines! Our client, based in Basel, is looking for a Principal Biostatistician for a 9 months contract. Your Tasks: 1. Study level: a. Responsible for all statistical tasks on assigned trials, and perform these tasks independently seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician. b. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. c. Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. d. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness of status and issues related to the as-signed trials. e. Collaborate with other line functions. Explain statistical concepts in manner easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements as required. f. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. g. Oversee all Biostatistics resources and deliverables for assigned trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. 2. Project level: a. Contribute to project level activities as needed. b. Contributes to project team preparation for HA Advisory Committees and meetings. 3. Enterprise level: a. Participate in non-clinical project activities as needed b. Contribute to the review and implementation of health authority guidances c. Promote the use and the acceptance of innovative methods within the organization, through scientific collaborations, publications in scientific peer reviewed journals and presentations at professional meetings 4. External level: a. Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate. b. Represent the company in statistical discussions at external congresses, conferences, scientific meetings. 5. People Management: Mentor new hires and/or junior Statisticians Your Profile: . MS (in Statistics or equivalent) with 4+ years relevant work experience or PhD (in Statistics or equivalent) with relevant work experience (including internship) . Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e.g. SAS, R). Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives. . Experience in Franchise/Therapeutic Area and/or regulatory activities desirable. Do not waste any minutes, apply now! We are looking forward to receiving your application. Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered. Skills:
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