TEMPOPHARMA

1 Job

24 Employees

About the Company

TempoPHARMA is company of MultiHealth Group, a group providing specialized services in the clinical development of health products. For almost 20 years, TempoPHARMA assists pharmaceutical, medical device, biotechnologies, food and dermocosmetic industries with four types of services : outsourcing, pre-hiring, recrutment and externalised platform. TempoPHARMA is specialised in outsourcing and recruitment in the health care sector.

Listed Jobs

Company Name: TEMPOPHARMA
Job Title: Biostatisticien Senior H/F
Job Description: **Job Title** Senior Biostatistician (H/F) **Role Summary** Lead biostatistical activities for interventional clinical trials, including study design, statistical analysis planning, data management integration, and reporting. Works closely with clinical teams, data managers, and regulatory entities to ensure methodological rigor and compliance with industry standards. **Expectations** - Minimum 5 years’ experience in a clinical trial biostatistics role. - Proven expertise in clinical trial methodology, sample size, and design selection. - Strong command of R, SAS, and SPSS; proficient in CDISC standards. - In-depth knowledge of regulatory requirements (BPC, ICH, EMA, CNIL, etc.). - Excellent written and oral communication skills; ability to train and guide teams. **Key Responsibilities** 1. Design study methodology: sample size calculations, design choices, eCRF review. 2. Draft statistical analysis plan and contribute to protocol development. 3. Collaborate with data managers on database design and validation. 4. Program, execute, and validate statistical analyses for assigned studies. 5. Conduct data review meetings; present findings to scientific committees. 6. Produce clinical study reports and summary documents. 7. Update and maintain quality procedures and documentation. **Required Skills** - Advanced statistical software proficiency (R, SAS, SPSS). - CDISC standards (SDTM, ADaM) expertise. - Comprehensive understanding of clinical trial regulatory frameworks (BPC, ICH guidelines, EMA regulations, CNIL data protection). - Strong analytical, problem‑solving, and project management capabilities. - Effective communication and stakeholder management. **Education & Certifications** - Minimum Master’s degree (Bac+5) in Statistics, Biostatistics, Epidemiology, or related scientific field. - Additional biostatistics training or certification strongly preferred.