Sr Statistician

Responsibilities

• Point of contact in supporting statistical approaches for cross-functional teams. Participate in the planning of associated experimental designs, analyses, and interpretation of results.
• Advanced skills in at least one statistical analysis and visualization software package (e.g., R, JMP, SAS)
• Application of statistical methodologies over a spectrum of R&T projects (e.g., imaging analysis studies, process characterization studies, multivariate process optimization, CPV, specification setting, comparability studies, shelf-life analysis, control charting and process capability analysis, etc.)
• Develop applications, tools, and methodological best practices for statistical analyses in collaboration with other members of non-clinical statistics.
• Contribute to development of reports for regulatory submissions and support health authority inspections. Conduct interactions with regulatory authorities as needed to support statistical approaches for analyses provided in submissions, information requests, or post-approval filings.
• Assist in preparation of statistical courses and provide training to scientists.

Education and Experience Requirements

• Typically, PhD or Master’s degree in statistics with 3-5 years of relevant experience in applying statistical methodologies.
• Experience in pharmaceutical development and statistical consulting.
• Proficiency in statistical and visualization software with R, JMP, and / or SAS.
• Proven experience in direct interactions with regulatory agencies is preferred.

Key Skills, Abilities, and Competencies

• In-depth knowledge of experimental design and analysis, variance components estimation, mixed models, and multiple industrial statistical problem-solving techniques.
• In-depth knowledge of statistical methodologies as applied to meeting global regulatory requirements.
• Excellent written and verbal communication skills to report and present results to internal stakeholders as well as external collaborators and agencies.
• Knowledge and understanding of application of standard business procedures (SOPs, guidance documents, etc.)
• Understanding of CMC, bioanalytical and / or pre-clinical research aspects of drug development.
• Proven success in collaborating with key stakeholders across different disciplines.
• Experience in gene therapy discovery and development preferred.

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees.

The base salary range for this position is currently from $97,300 to $146,000.

Spark Therapeutics does not accept unsolicited resumes / candidate profiles from any source other than directly from candidates.

Any unsolicited resume / candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.

Total Rewards : Compensation & Benefits

Spark® offers a competitive, flexible, and comprehensive Total Rewards package that can be customized to fit your personal needs.

Our program is designed to support the holistic wellbeing of employees and their families by providing health coverage, retirement savings plan, and a range of voluntary benefits for financial protection and peace of mind.

For all employees, our core total rewards package includes industry competitive salaries; bonus eligibility; and long-term incentive eligibility, including both new hire and annual grant opportunities.

We do everything we can to make working at Spark rewarding for you.

Your Health & Wellbeing

• Medical and Prescription Drugs
• Dental and Vision
• Health Advocate
• Health Savings Accounts (HSA)
• Flexible Spending Accounts (FSA)

Your Financial Protection

• 401(k) Retirement Savings Plan
• Financial Planning
• Life and Disability Insurance
• Identity Theft Protection
• Discounted Pet, Auto, and Home Insurance

Your Work / Life Balance

• Time Away from Work Paid Time Off (PTO) Use for vacation, illness or personal timeHolidays Observance of up to 12 designated holidays, two floating holidays, plus a winter shutdownVolunteer Days Up to two volunteer days per yearSpark Unplugged Half Days Designated alternate half day Fridays year-roundPaid Parental Leave Fully paid pregnancy leave up to 16 weeks total for birth mothers and up to eight weeks for parents
• Mental Health Support Program which includes coaching and therapy
• Employee Assistance Program (EAP)
• Tuition Reimbursement Program
• Mobile Phone Allowance
• Company Paid Commuter Program
• Adoption Assistance Program
• Care@Work Membership
• LifeMart Discount Program

that are made available in response to the federal Transparency in Coverage Rule and includes negotiated service rates and out-of-network allowed amounts between health plans and healthcare providers.

The machine-readable files are formatted to allow researchers, regulators, and application developers to more easily access and analyze data.