赛诺菲
Principal Biostatistician (VAX)
Principal Biostatistician (VAX)
发布于 大约 15 小时前普通员工/个人贡献者
Hyderabad, India
高级经验
全职员工
仅现场办公
硕士
医疗、制药与临床研究
SAS
SDTM
ADaM
CDISC
AI 估算 · 15k–30k
Senior biostatistician in Indian pharma hub, expertise in vaccines and regulatory submissions commands premium.
职位详情
关于这个职位
This is a senior-level biostatistics role within Sanofi's Vaccines R&D team, based in Hyderabad. You will lead statistical activities for vaccine clinical trials, from study design through reporting and regulatory submissions. The position offers the opportunity to work on innovative vaccines that protect millions globally.
最低要求
PhD or Masters degree in Statistics (preferred), Mathematics or related health sciences or equivalent experience
+ years' experience in clinical Biostatistics and Programming research, including at least 3-5 years in Vaccines
Experience in acting end to end as Study Biostatistician
Experience in leading programmers through e-submission statistical activities
Experience in performing complex exploratory statistical analyses
Consistent successful experience as a lead on several concurrent studies/projects (programming experience in SAS and R)
Demonstrate knowledge of CDISC (SDTM/ADaM/SEND)
Excellent understanding of clinical trial processes
Strong project management skills
Highly effective communication in English
工作职责
Support the clinical study design (including concept protocol development), the study setup, conduct and reporting.
Accountable for all assigned statistical study deliverables: develop statistical sections in protocol; ensure protocol is statistically sound; contribute to randomization specifications; develop Statistical Analysis Plan; plan and execute statistical data surveillance; perform data analysis; contribute to interpretation of results; ensure clinical study report statistical integrity.
Develop Integrated Analysis Plan for Safety or Immunology Summaries. Conduct related analyses for submission Core Technical Dossier.
Work with programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan. Perform and/or coordinate production of statistical analyses and CDISC compliant data package.
Propose, prepare and perform complex exploratory data analyses, ad-hoc analyses for study objectives or Health Authorities questions.
Provide statistical insight into interpretation of results; use strong communication skills to present and explain methodology.
Ensure productive collaborations with other functions; promote teamwork, quality, operational efficiency, and innovation.
Represent statistics to participate in scientific or technology working groups or cross function initiatives.
AI 洞察
优缺点分析
优点
- Work on life-saving vaccines with global health impact.
- Access to extensive resources at a top-tier pharmaceutical company.
- High autonomy and responsibility in study leadership.
- Exposure to full R&D value chain from preclinical to submission.
- High regulatory and quality standards require meticulous attention to detail.
- Managing multiple concurrent studies can be stressful with tight deadlines.
- Requires deep specialization in vaccines, which may limit mobility to other therapeutic areas.
- Ideal for experienced biostatisticians passionate about public health and seeking a leadership role in a structured, global environment.
缺点 / 挑战
暂无明显挑战项
角色解读
- Advance to Associate Director or Director of Biostatistics within Sanofi's R&D.
- Broaden impact by leading global submissions or cross-therapeutic area initiatives.
- Transition into drug development leadership, combining statistical and strategic expertise.
- Design and oversee statistical aspects of vaccine clinical trials, from protocol development to final study report.
- Lead complex exploratory data analyses and ensure regulatory-compliant data packages (CDISC).
- Collaborate cross-functionally with clinical, programming, and regulatory teams to drive study success.
- Deep expertise in clinical biostatistics, especially vaccine trial designs and endpoints.
- Proficiency in SAS and R for statistical programming and CDISC standards.
- Strong project management skills to handle multiple studies and priorities.
- Excellent communication to explain statistical methodology to non-statisticians.
申请策略
- Tailor your CV to reflect vaccine experience explicitly, using keywords from the job description.
- Prepare a brief presentation on a past study to demonstrate your statistical leadership.
- Emphasize end-to-end study biostatistician experience with specific vaccines examples.
- Showcase successful regulatory submissions (e.g., ISS, ISE) and CDISC expertise.
- Highlight leadership in managing programmers and cross-functional collaborations.
- Quantify impact: number of studies led, sample sizes, regulatory outcomes.
- Deepen knowledge of vaccine-specific statistical methods (e.g., non-inferiority, immunogenicity).
- Get certified in CDISC standards or attend workshops on advanced SAS/R techniques.
面试指南
- Use STAR method: Situation, Task, Action, Result. Focus on your specific role and quantitative outcomes.
- For technical questions, walk through your thought process step-by-step, showing domain knowledge.
- For communication questions, demonstrate empathy and simplification skills.
- Describe a challenging vaccine trial design and how you addressed statistical issues.
- How do you ensure CDISC compliance in a dataset for submission?
- Tell us about a time you led a team of programmers for an e-submission.
- How would you handle a request from Health Authorities for additional analyses?
- Explain a complex statistical method to a non-statistician colleague.
职位点评
72
综合评分
Senior biostatistics role in vaccines R&D with strong purpose and development, but limited work flexibility.
更适合这类人
Candidates driven by purpose and career growth in life sciences, who are comfortable with on-site work and can handle high responsibility.
表现最好
使命价值
相对薄弱
工作生活
薪资福利75
成长发展85
工作生活40
使命价值90
薪资福利
75中等
Salary is competitive for senior biostatistician in Hyderabad, but not disclosed. Sanofi offers standard pharma benefits, but no specifics in JD.
薪资信号未披露（AI估算：15K-30K/月）
成长发展
85较高
The role provides growth through exposure to full vaccine R&D, regulatory submissions, and leadership opportunities. 'Eager to learn' and 'opportunities to learn' indicate learning culture.
技术前沿主流现代技术
技术栈SAS、R、CDISC、SDTM、ADaM
成长机会opportunities to learn、grow、developing capacities
业务类型profit_center
工作生活
40较低
Work mode is on-site at Hyderabad hub, no mention of flexibility. No WLB signals in JD.
工作模式仅现场办公
办公地点未明确
加班情况未提及（无法判断）
使命价值
90较高
Directly contributes to vaccine development, improving global health. Mission-driven company with strong social impact.
行业发展高速增长赛道
社会影响正向社会影响力较高
使命信号protect people、promote healthy communities、improve people's lives
创新程度积极采用新技术
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