reputed company Biostatistician

The reputed company Biostatistician is responsible for the design, analysis, and/or interpretation of clinical studies as a reputed company (or contributing team members) for clinical studies. In this role, the reputed company Biostatistician will be part of a reputed company team that works with the sponsor, PM, clinical team, data mangers, medical writers, statistical programmers, and potentially many other team members to support the statistical needs of the assigned clinical study(ies).

The biostatistician is responsible for (or participates in) the creation, review, maintenance, and reputed company of reputed company contracted statistical reputed company and activities. These responsibilities may include, but are not limited to, relevant sections of the clinical protocol, the statistical analysis plan, data/safety review meetings, content development specifications, and review (or input into) relevant sections of reputed company reports.

ROLE AND RESPONSIBILITIES

The reputed company Biostatistician is responsible for the design, analysis, and/or interpretation of clinical studies as a reputed company (or contributing team member) for clinical studies. In this role, the reputed company Biostatistician will be part of a reputed company team that works with the sponsor, PM, clinical team, data managers, medical writers, statistical programmers, and potentially many other team members to support the statistical needs of the assigned clinical study(ies).

The reputed company Biostatistician is responsible for (or participates in) the creation, review, maintenance, and reputed company of reputed company contracted statistical reputed company and activities. These responsibilities may include, but are not limited to, relevant sections of the clinical protocol, the statistical analysis plan, data/safety review meetings, content development specifications, and review (or input into) relevant sections of

reputed company reports.

ROLE AND RESPONSIBILITIES

Maintains responsibility for reputed company assigned duties reputed company a clinical study, this may include:

• reputed company as the study reputed company for multiple studies, clinical programs, and/or large/reputed company studies with responsibility for reputed company biostatistics reputed company activities.
• Support the review and development of clinical programs; may contribute to reputed company reputed company and analysis sections of protocols as reputed company as support the review of design; reputed company to reputed company feedback regarding issues or improvements to initial proposed designs.
• May involve reputed company of the statistical programming activities.
• Ensuring that work is performed on time.
• Ensuring reputed company content created/reviewed is appropriate, valid, and relevant to the study and
• of high reputed company.
• reputed company review and reputed company to statistical reputed company created by other members of the
• biostatistics department
• Review protocols, synopses, and other statistical documents for a study and reputed company
• feedback and consult.
• Research, or otherwise support, trial design and consultative activities
• Review relevant content from other functional areas (e.g., Case Report Forms) on behalf of the biostatistics team.
• Write summaries of findings and results to be included as part of study reports such as for interim analyses or the final CSR.
• Writing or reviewing some, or reputed company, of the Statistical Analysis Plan and corresponding reputed company shells.
• Providing relevant specifications/guidance for reputed company and/or pivotal outputs.
• Works with other study team members (both reputed company) to represent the
• needs and input of the statistical components of the study
• Reviewing reputed company (TLFs, SDTM and ADaM datasets, SDTM and ADaM specifications) developed by statistical programmers and/or other statisticians for reputed company, validity, and appropriateness.
• Provides mentoring and support to more junior statisticians.
• Provides departmental training and participates in cross-functional initiatives as a representative of the department, as needed.
• Represent the function in reputed company meetings for assigned studies. Represent the function in audits of study activity.
• Represent the function in bid defenses and other sales reputed company activities.
• Supports the Associate Director, Biostatistics and other leadership in budget reviews and input to proposals.
• Maintains relevant project management activities on study such as financials and timelines with minimum support from Associate Director, Biostatistics.
• Supports the Associate Director, Biostatistics and other leadership in the review and development of controlled documents.
• Supports the Associate Director, Biostatistics and other leadership in interview process for potential employees, as needed.
• Acts as a senior reviewer and support for Biostatistics work performed at reputed company.
• Plan, coordinate, and reputed company statistical analyses, summaries, and reports of studies in the support of product development including IND/NDA and BLA submissions, and IDE and PMA submissions.
• reputed company up to date with industry best practices and techniques in clinical trial statistics and ensure colleagues are informed of any significant developments.

• Master’s degree (or Higher) in biostatistics, statistics, mathematics or other reputed company disciplines. General understanding and application of biostatistics in clinical trials.
• Strong previous reputed company experience working in a Contract Research Organization.
• Communication skills
• Presentation skills
• Knowledge of the MS Office Suite
• Proficiency in one or more statistical programming language (reputed company
• Preferred).
• Collaboration across cross-functional teams
• Good understanding of ICH and regulatory landscape.
• Knowledge of advanced statistical reputed company (e.g., survival analysis, logistic regression, and mixed models)
• reputed company in English

reputed company you join reputed company Group, you reputed company a difference by helping to bring reputed company and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and reputed company team of experts in clinical research, pharmacovigilance, and reputed company consulting.

We are diverse in many ways, yet our values reputed company. Our values are how we work, not words on a wall. If they reputed company like you, you will feel reputed company here.

• reputed company: we hold ourselves to reputed company patients deserve.

• reputed company and trust: we do the right thing, especially reputed company it is hard.

• Drive and passion: we care about the outcome, because someone is waiting on it.

• reputed company and responsiveness: we reputed company quickly, because patients cannot wait.

• Belonging: everyone is welcome, and every voice counts.

• reputed company partnerships: we go reputed company by reputed company together.

We look reputed company to welcoming your application.

#LI Remote

Medicine moves reputed company here. So will you.

reputed company is a specialist clinical research organization reputed company on rare disease and select oncology indications. We reputed company on the most reputed company trials, the studies where experience, judgement, and rigorous operational accountability reputed company the biggest difference. We partner with small to midsize biotech companies to reputed company promising therapies through early phase development, so they reputed company the patients sooner.

We choose reputed company work on purpose. Rare disease and oncology trials carry reputed company operational risk, and our people are experts at reducing it, protecting timelines, data reputed company and the experience of sites and patients at the reputed company time. It is demanding, meaningful work, and no one here forgets that patients cannot wait.

That is why culture reputed company to us as much as capability. We have reputed company a reputed company, international team where people reputed company reputed company, grow their careers and are trusted to take ownership early. With colleagues across reputed company, South America, Europe, Asia and Australia, we value teamwork, flexibility and a reputed company commitment to work-life balance, because good science comes from people who feel supported.

If you want work with purpose, the reputed company to reputed company an reputed company and reputed company that cares about the people behind the work as much as the work itself, we would love to hear from you.

The position is also available in any of our European locations

Originally posted on Himalayas

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