Senior Principal Biostatistician at Alcon

Fort Worth, Texas, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Medical Devices, OphthalmologyIndustries

Requirements

PhD in statistics or biostatistics and at least five years of experience in the pharmaceutical, biotechnology, or CRO industry with a proven record in the design and analysis of clinical trials, OR Master's degree in statistics or biostatistics with at least ten years of experience
Proficiency in statistical programming with SAS and/or R
Hands-on expertise in mixed models for repeated measures (MMRM)
Expertise in multiple-imputation techniques for missing data under varied assumptions
Solid working knowledge of the ICH E9(R1) estimand framework

Responsibilities

Provide scientific and technical leadership and management of multiple projects in one or more therapeutic areas in biostatistics across multiple projects, ensuring robust statistical methodologies support product development strategies, regulatory submissions, and post-marketing activities
Lead the development of clinical and non-clinical study designs, statistical analysis plans, and data interpretation to determine safety, efficacy, and marketability
Independently assist in creation of development plans and lead scientific development of all related protocols for multiple projects
Independently lead all efforts related to project-level activities, including all analyses and inputs into regulatory filings for all phases of development as well as medical affairs activities, including support for publication and conference presentations
Manage complex statistical challenges across therapeutic areas, guiding teams through all phases of clinical development, including regulatory interactions and submissions
Oversee statistical programming efforts, ensuring quality, timeliness, and efficiency in deliverables while providing mentorship and strategic guidance to programmers and statisticians
Develop and optimize business and technical processes related to statistical systems and data management, formulating operational specifications and integrating innovative data solutions
Lead system development initiatives, coordinating project execution, testing, training, change management, and system upgrades
Act as a key liaison between business and technology teams, defining statistical and data processing requirements to enhance operational efficiencies
Partner with cross-functional teams to ensure statistical strategies align with broader business and regulatory objectives, proactively identifying risks and implementing mitigation plans to drive success
Ensure and manage quality, timeliness, and efficiency for all support and deliverables for designated projects
Liaise with and provide needed guidance to statistical programmers assigned in support of project and trial deliverables
Include the accountabilities of statisticians assigned to projects
Establish and maintain working relationships with project-specific functional representation

Skills

Biostatistics

Statistical Analysis Plans

Study Design

Data Interpretation

Regulatory Submissions

Clinical Trials

Statistical Programming

Protocol Development

Alcon

Specializes in eye care products and solutions

About Alcon

Alcon specializes in eye care products and vision solutions aimed at improving people's quality of life through better vision. Their product offerings include solutions for cataract surgery, retinal health, and contact lenses. Alcon's products work by utilizing advanced technology and research to provide effective treatments and aids for various eye conditions. What sets Alcon apart from its competitors is its strong emphasis on research and development, ensuring that they remain leaders in the eye care industry. The company's goal is to enhance vision and overall quality of life for individuals while promoting a diverse and inclusive workplace.

Geneva, SwitzerlandHeadquarters

1945Year Founded

IPOCompany Stage

Social Impact, HealthcareIndustries

10,001+Employees

Benefits

Medical, dental, & vision coverage

HSA Medical Plan

PTO

Paid Parental leave

401k

Retirement Plan Company Contribution

Low payroll deductions

Tuition Reimbursement Program

Annual Bonus

Free Family Contact Lens Program

12 Company Paid Holidays

Risks

FDA recall of contact lenses may harm Alcon's reputation and financial standing.

Antitrust case denial could lead to legal challenges and financial penalties.

Innovative competitors like Signal12 threaten Alcon's market share in eye care.

Differentiation

Alcon leads in eye care with a broad product portfolio and global reach.

The company invests heavily in R&D, ensuring cutting-edge vision solutions.

Alcon's commitment to diversity and inclusion strengthens its corporate culture.

Upsides

Acquisition of BELKIN Vision enhances Alcon's glaucoma treatment options with DSLT technology.

Orbis Flying Eye Hospital project boosts Alcon's global presence and eye care standards.

Recognition as a top employer in Singapore attracts and retains top talent.

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