Clinical Outcomes Solutions
Clinical Outcomes Solutions
Clinical Outcomes Solutions एक वैश्विक परामर्श संस्था है, जो फार्मास्यूटिकल और जैव-प्रौद्योगिकी संगठनों के लिए क्लिनिकल आउटकम असेसमेंट (COA) अनुसंधान पर केंद्रित है। इसकी टीम अनुसंधान रणनीतियाँ और व्यावहारिक समाधान विकसित करती है, ताकि रोगियों के अनुभवों से संबंधित विश्वसनीय डेटा एकत्र किया जा सके और ग्राहकों को क्लिनिकल परिणामों से जुड़े वैज्ञानिक तथा नियामक जटिलताओं से निपटने में सहायता मिल सके। अनुसंधान की रूपरेखा और साक्ष्य निर्माण में रोगियों की आवाज़ को शामिल करके, कंपनी सूचित देखभाल संबंधी निर्णयों और बेहतर रोगी परिणामों का समर्थन करती है।

Principal Biostatistician, FSP – UK Remote

Provide biostatistical support across Phase I–IV clinical trials and regulatory submissions for Cytel’s pharmaceutical clients. Develop SAPs, analyze clinical data, and contribute to integrated clinical study reports.

विवरण

  • Support Phase I–IV clinical studies
  • Conduct ad hoc and exploratory analyses for submissions and Health Authority questions
  • Provide statistical guidance throughout clinical studies
  • Contribute to protocol development, study design discussions, and sample size calculations
  • Review CRFs and data review guidelines
  • Create statistical analysis plans, including analysis dataset and TLG specifications
  • Execute statistical analyses and interpret the findings
  • Prepare clinical study reports, including integrated submission summaries
  • Explain statistical methods and the implications of key decisions
  • Work fully embedded with a global pharmaceutical client while receiving support from Cytel
  • Partner with clinical, regulatory, programming, internal, and external teams

आवश्यकताएँ

  • Master’s degree in statistics or a related field
  • At least 3 years of clinical-trial support experience in the pharmaceutical or biotechnology industry
  • CRO experience is strongly preferred
  • Experience with sample size calculations, protocol concept and protocol development, SAPs, and clinical study reports with integrated submission summaries
  • Strong SAS programming skills for quality control of critical outputs and efficacy and safety tables, with the ability to work closely with programmers
  • Strong understanding and practical application of CDISC requirements for regulatory submissions
  • Proficiency in generating ADaM specifications and performing dataset quality control
  • Ability to build effective external and internal relationships and motivate regional or global teams
  • Clear communication skills, including the ability to explain methodologies and decision implications in plain language
  • Knowledge of R programming is advantageous
  • Regulatory work experience is an advantage

लाभ

  • Ongoing training, development, and support
  • Strong opportunities for professional growth
  • Professional development opportunities

संबंधित नौकरियाँ

EXL

Accounts Receivable Executive – Finance & Accounting, EXL (Hybrid, Noida)

EXL

Support EXL’s Accounts Receivable operations, including customer records, cash application, collections, and reconciliations. This is a hybrid role based in Noida, India.

खोलें
Viridor

HR Administrator

Viridor

Provide onboarding and employee lifecycle administration, handle HR queries, and support compliance for Viridor’s People & Culture team. The role is based in the United Kingdom with a hybrid working arrangement.

खोलें
HR Ways - Hiring Tech Talent

Recruiter, Pakistan (Remote)

HR Ways - Hiring Tech Talent

Recruit couriers, operators, warehouse staff, and other employees in Pakistan for an international dietary supplements company. Handle sourcing, interviews, onboarding, and daily hiring data remotely.

खोलें
Cambium Learning Group

Senior Human Resources Business Partner

Cambium Learning Group

Shape business-unit people strategy at Cambium Learning Group by advising executives on organizational design, talent, and change. Lead workforce planning, succession, and employee relations in a remote role based in the United States.

खोलें
Surge Staffing

Onsite Staffing Specialist — Surge Staffing, Newark, Ohio

Surge Staffing
1,001 – 5,000 कर्मचारी
एचआर टेकभर्ती

Recruit and onboard candidates for Surge Staffing clients while building customer relationships, developing sales leads, and helping run branch operations.

खोलें
Taktile

Senior Recruiter, Go-to-Market

Taktile
51 – 200 कर्मचारी
फिनटेकबैंकिंग

Lead go-to-market hiring at Taktile, whose AI platform helps financial institutions automate decisions. Shape sourcing strategies, hiring practices, and the candidate experience.

खोलें
Taktile

Senior GTM Recruiter

Taktile
51 – 200 कर्मचारी
फिनटेकबैंकिंग

Lead go-to-market recruiting at Taktile, from sourcing strategy and hiring manager partnership through offer close. Shape a clear candidate experience and strengthen recruiting operations as the company grows.

खोलें
FUJIFILM Corporation

Senior HR Operations Manager

FUJIFILM Corporation

Lead employee lifecycle operations, compliance, reporting, and performance management for FUJIFILM Biosciences. The role is based onsite in Santa Ana, California.

खोलें
Veralto

Senior Director of Human Resources

Veralto

As Veralto’s senior HR partner, shape talent, organizational, and culture strategy across the global corporate organization. Lead workforce planning, succession, core HR programs, and a small team.

खोलें
SelectLine Software Gmbh

Talent Acquisition Manager

SelectLine Software Gmbh

Lead end-to-end recruiting at SelectLine Software, a German software company. Manage sourcing, selection, candidate experience and employer branding in a hybrid role.

खोलें