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Principal Biostatistician-Clinical Statistics

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Sanofi

3mo ago

  • Job
    Full-time
    Senior & Expert Level
  • Hyderabad, +1

AI generated summary

  • You need clinical trial experience, strong stats knowledge, proficiency in SAS/R, an MS/PhD in Statistics, and excellent English communication skills.
  • You will design clinical studies, conduct statistical analyses, prepare reports, ensure compliance, collaborate with teams, and lead exploratory analyses while maintaining statistical integrity.

Requirements

  • Experience: Pharmaceutical or related industry experience with clinical trials.
  • Soft skills: Demonstrated interpersonal and communication skills.
  • Good knowledge and good understanding of statistical concepts and techniques
  • Good knowledge of pharmaceutical clinical development
  • Technical skills: Able to work in departmental computing environment, can do advanced statistical analyses using SAS, R and other languages.
  • Education: MS or PhD degree in Statistics or relevant fields
  • Languages: Highly effective communication in English, both oral and written.

Responsibilities

  • Support the clinical study design (including protocol development), the study setup and conduct.
  • Conduct the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.
  • Accountable for all assigned statistical deliverables related to one study or specific domain: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology etc., SAP, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables) …
  • Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives. Contribute to define and review the specific deliverables related to Transparency and Disclosure.
  • 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.
  • Review and examine statistical data distributions/properties.
  • 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.
  • Represent statistics to participate in scientific or technology working groups or cross function initiatives.

FAQs

What is the job title for this position?

The job title for this position is Principal Biostatistician-Clinical Statistics.

Where is the job located?

The job is located in Hyderabad, India.

What is the main responsibility of the Principal Biostatistician?

The main responsibility is to lead or support one or several early/late phase studies under minimum supervision of the statistical team leader.

What are the qualifications required for this role?

The qualifications required include an MS or PhD degree in Statistics or relevant fields, along with pharmaceutical or related industry experience with clinical trials.

What technical skills are needed for this position?

Candidates should have the ability to conduct advanced statistical analyses using SAS, R, and other programming languages.

What type of experience is necessary for applicants?

Applicants should have experience in the pharmaceutical industry or related fields, specifically with clinical trials.

What soft skills are emphasized for this role?

Demonstrated interpersonal and communication skills are emphasized as important soft skills for this role.

Are there opportunities for career growth within the company?

Yes, there are endless opportunities to grow your talent and drive your career, whether through promotions or lateral moves, both locally and internationally.

What benefits does the company offer?

The company offers a comprehensive rewards package that includes health and wellbeing benefits, high-quality healthcare, prevention and wellness programs, and at least 14 weeks of gender-neutral parental leave.

How does the company support work-life balance?

The company supports work-life balance with a thoughtful benefits package that includes various health and wellbeing initiatives.

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Sanofi

Science & Healthcare
Industry
10,001+
Employees
2004
Founded Year

Mission & Purpose

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.