Título del trabajo: Senior Statistician (Coyol, Alajuela)

Compañía: Smith & Nephew

Descripción de funciones: Senior Statistician (Coyol, Alajuela)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

Ing Civil Por Servicios Profesionales

Are you looking for a new opportunity where you can develop yourself? The Senior Statistician will be responsible for developing innovative methodologies and generating trusted results to support a variety of studies across our Advanced Wound Management, Orthopedics, and Sports Medicine & ENT global portfolios. This will include working cross-functionally to develop clinical study designs and protocols, and hybrid study designs that leverage sources of external evidence such as large real-world datasets. The successful candidate will be first and foremost a lifelong learner. They will have a great foundation in clinical biostatistics and a true passion for innovation.

For internal candidates only: P3

What will you be doing?

Study Design and Planning:

Provide experienced statistical input and mentorship in the development of clinical study protocols, including sample size calculation, randomization, hybrid study designs, real-world evidence studies, and statistical analysis plans

Collaborate with cross-functional teams to define study objectives, endpoints, and statistical considerations, ensuring alignment with regulatory requirements and business goals

Statistical Analysis:

Conduct comprehensive statistical analyses of clinical study data, applying appropriate methods such as descriptive and inferential statistics, survival analysis, regression analysis, subgroup analysis, and propensity score analysis (matching, stratification, weighting, covariate adjustment) as vital

Leverage statistical software tools such as SAS to generate accurate and reliable results, and learn new languages/tools/techniques as needed

Perform advanced statistical modeling and study simulation techniques to support decision-making and optimize study designs

Data Management and Quality:

Conduct thorough data review and quality control checks to identify any discrepancies or outliers, ensuring data integrity and reliability

Results Interpretation and Reporting:

Prepare and present statistical analysis results, study findings, and statistical methodologies to internal stakeholders, project teams, and regulatory authorities

Contribute to the development of Clinical Study Reports (CSRs), statistical sections of regulatory submissions, and other relevant documents

Statistical Expertise and Guidance:

Stay abreast of the latest statistical methodologies, industry standards, and regulatory guidelines relevant to medical device clinical studies

Provide statistical expertise to guide internal teams, including mentoring junior statisticians and cross-functional colleagues on statistical concepts and methods

What will you need to be successful?

Education: At least a bachelor’s degree in a relevant field (e.g., biostatistics, statistics, mathematics, physics, data science).

A relevant graduate degree is strongly preferred.

Experience: At least 3 years as a clinical statistician in an academic or industry setting.

Languages: Advanced English Level.

Knowledge: Proficiency in SAS.

Familiarity with R (preferred).

Strong knowledge of statistical methodologies, study design, and clinical trial regulations/guidelines (e.g., FDA, ISO).

Experience in version control such as Git (preferred)

Experience with CDISC standards and working with large clinical trial datasets (preferred)

Competencies: Excellent communication skills, with the ability to clearly and concisely communicate statistical concepts to non-statistical customers.

Strong problem-solving skills, curiosity to investigate and learn more, aim to innovate, and the ability to work either independently or as part of a team.

Strong communication, time management, and passion/motivation are critical in this remote position.

Confirmed experience in the analysis and reporting of clinical study data, including the preparation of CSRs and statistical sections of regulatory submissions.

Experience in clinical study simulation to predict clinical outcomes or inform clinical study design.

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about on our website.

Other reasons why you will love it here!

Your future: stock purchase program, referral bonus, subsidy in transport and food, recognition program.

Work/Life Balance: Extra days off, birthday off, voluntary hours.

Your Wellbeing: company doctor, medical insurance, gym, health campaigns, employee assistance program, parental leave,

Flexibility: Hybrid work model (for more professional roles), flexible schedules.

Training: Training program, unlimited learning.

Extra perks: employees association, and more…


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Ubicación: Alajuela

Fecha del trabajo: Thu, 11 Jan 2024 03:07:49 GMT