Sr. Statistician (REMOTE - US)

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

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 strong foundation in clinical biostatistics and a true passion for innovation.

What will you be doing?

Study Design and Planning:

• Provide expert statistical input and guidance 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, utilizing appropriate methods such as descriptive and inferential statistics, survival analysis, regression analysis, subgroup analysis, and propensity score analysis (matching, stratification, weighting, covariate adjustment) as necessary.

• 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 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: 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 stakeholders.

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

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

• Proven 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.

The anticipated compensation range for this position is $115,000.00 - $135,000.00 USD annually and the compensation offered will depend on the candidate's qualifications. You may also be entitled to receive bonus and benefits, which may include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings.

Smith & Nephew follows the Pay Transparency and non-discrimination provisions described by the by local and state policies.

To be considered for this role, please submit your application by 12/12/2024."

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Flexibility: Hybrid Work Model (For most professional roles)

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more

#LI-LS2

#LI- REMOTE

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.