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141 Sanofi Jobs
Senior Biostatistician (VAX)
Sanofi
posted 4mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
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 (i
e
statistical methodology, sample size calculation, ); ensure protocol is statistically sound; contribute to randomization specifications and set-up; develop Statistical Analysis Plan; plan and execute statistical data surveillance; perform data analysis; contribute to interpretation of results with the Project Biostatistician; ensure clinical study report statistical integrity and the specific deliverables related to Transparency and Disclosure
e
statistical methodology, sample size calculation, ); ensure protocol is statistically sound; contribute to randomization specifications and set-up; develop Statistical Analysis Plan; plan and execute statistical data surveillance; perform data analysis; contribute to interpretation of results with the Project Biostatistician; ensure clinical study report statistical integrity and the specific deliverables related to Transparency and Disclosure
Develop Integrated Analysis Plan for Safety or Immunology Summaries
Conduct related analyses in collaboration with programming and deliver outputs for submission Core Technical Dossier
Conduct related analyses in collaboration with programming and deliver outputs for submission Core Technical Dossier
Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan
Perform and/or coordinate with study programmer the production of statistical analyses and CDISC compliant data package, ready for submission
Perform and/or coordinate with study programmer the production of statistical analyses and CDISC compliant data package, ready for submission
Propose, prepare and perform complex exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives and/or in answering Health Authorities questions
Provide statistical insight into interpretation of results in line with other sponsored studies and competition results
Use strong communication skills to present and explain the methodology chosen and consequences in results interpretation and decisions
Use strong communication skills to present and explain the methodology chosen and consequences in results interpretation and decisions
Ensure productive collaborations with other functions in the aligned study team and/or safety monitoring team and in communicating with senior leadership
; Promoting teamwork, quality, operational efficiency, and innovation
; Promoting teamwork, quality, operational efficiency, and innovation
Represent statistics to participate in scientific or technology working groups or cross function initiatives
About you
You are a passionate leader with following experience and competences who like the challenge and growing into a new environment:
Experience:
5+ years experience in clinical Biostatistics and Programming research, including at least 3-5 years in Vaccines (trial designs, endpoints, statistical methods, )
o Experience in acting end to end as Study Biostatistician (ie, nonstandard sample size, statistical section of protocol, randomization set-up with vendor, Statistical Analysis Plan, analyses, study report, publication )
o Experience in leading programmers through some e-submission statistical activities (e
g
ISS, ISE, and/or ISI)
g
ISS, ISE, and/or ISI)
o Experience in performing complex exploratory statistical analyses without written specifications
o Consistent successful experience as a lead on several concurrent studies/projects (programming experience in SAS and R)
o Demonstrate knowledge of CDISC (SDTM/ADaM/SEND) including specifications, P21, define
xml, Reviewers Guide
xml, Reviewers Guide
Skills:
o Excellent understanding of processes associated with clinical trials, including knowledge of interfaces and interdependencies with other functions
o Demonstrate interpersonal/teamwork in technical and leadership skills
o Strong projects management skills
o Clear ability to organize multiple work assignments to a team and establish priorities
o Understand and able to contribute to resourcing strategy implementation, developing capacities and capabilities
o Eager to learn and explore new territories
Education:
o MSC-stats/PhD degree in Statistics (preferred), Mathematics or related health sciences or equivalent experience
Languages:
o English: Highly effective communication, both oral and written
Employment Type: Full Time, Permanent
Read full job descriptionPrepare for Biostatistician roles with real interview advice
Top Sanofi Biostatistician Interview Questions
Q1. How many Indians have health insurance? What percent of them use health insurance for conservative treatment solutions?
asked in
Intern interview
Q2. What is the current scenario of the pharma market in India?
asked in
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Q3. What are the steps you follow to write a manuscript from scratch?
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Scientific Writer interview
What people at Sanofi are saying
Biostatistician salary at Sanofi
reported by
5
employees
with 4-7
years exp.
₹9
L/yr - ₹13.2
L/yr
124%
more
than the average Biostatistician Salary in India
View more details
What Sanofi employees are saying about work life
based on 1.2k employees
Flexible timing
Monday to Friday
Within city
Day Shift
Sanofi Benefits
View more benefits
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