Principal Scientist, Stat. Programming- Early Oncology Development (Hybrid)

Merck & Co.; Upper Gwynedd Township (Montgomery County); On-site; USD 173,200 - 272,600; Full time

Job summary

Merck & Co. is seeking a Senior Statistical Programmer in BARDS to partner with statisticians on strategic analyses for early stage development.

The role focuses on increasing efficiency and compliance by delivering non-standard analyses with SAS/R, and collaborating across Statistics, Clinical Research, Data Management, Regulatory, Clinical Safety, and PK/PD Modeling. The successful candidate will develop and implement programming standards, lead cross-functional teams, and tackle large,

Qualifications

• Minimum 12 years SAS/R programming in a clinical trial environment with BA/BS, or 10 years with MS.
• Experience developing analyses and reporting deliverables for R&D projects (datasets, analyses, tables, graphics, listings).
• Ability to design complex programming algorithms and interpret analysis plans.

Responsibilities

• Provide technical consultation and analytical support to early development statisticians for exploratory analyses.
• Address operational challenges with strategic solutions across early oncology development.
• Develop programming standards to enable efficient, high-quality production of deliverables.
• Lead departmental strategic initiative project teams and collaborate with multiple stakeholders.

Skills

SAS programming

R programming

Clinical trial programming

Data steps and SAS/GRAPH

Leadership across programs

Strategic thinking

Education

BA/BS in Computer Science, Statistics, Applied Math, Life Sciences, Engineering or related field

MS in related field with 10+ years SAS/R in clinical trials

Tools

SAS/macros

SAS/GRAPH

CDISC ADaM

Job description

Job Description

Statistical Programming is in the Biostatistics and Research Decision Sciences (BARDS) department at our company's Research & Development Labs which supports the targeting, discovery, development, manufacturing, and marketing of drugs and vaccines for the benefit of patients and global public health.

This position focuses on strategic activities impacting early stage development projects to the direct benefit of project teams and the Biostatistics organization. The principal statistical programmer will partner with statisticians to solve problems; reduce the amount of programming task being completed by statisticians to facilitate an increase in efficiency and compliance for statistical analyses. The incumbent will write programs to analyze data with statistical methods which are not currently available through commercial software packages.

The position is a key collaborator with internal and external stakeholders including Statistics, Clinical Research, Data Management, Regulatory, Clinical Safety, and PK/PD Modeling and Simulation organizations.

Primary Activities

• Provide technical consultation and analytical support to early development statisticians for exploratory and unplanned statistical analyses
• Address operational challenges that require strategic solutions across early oncology development
• Support the development of programming standards to enable efficient and high quality production of programming deliverables
• Facilitate global adoption of standards and programming best practices within the early oncology space
• Pre-process, filter, and manipulate complex data for the analyses of molecular biomarker data, imaging data, and external data other than traditional laboratory data
• Lead and actively contribute to departmental strategic initiative project teams

Education and Minimum Requirements

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with a minimum of 12 years SAS/R programming experience in a clinical trial environment, or an MS in a related field with a minimum of 10 years SAS/R programming experience in a clinical trial environment

Department Required Skills and Experience

• Excellent interpersonal skills and ability to negotiate and collaborate effectively
• Excellent written, oral, and presentation skills
• Superior knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
• Excellent project management skills; leadership across multiple and complex programs; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders

Position Specific Required Skills and Experience

• Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH
• Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) according to quality, compliance and timeliness requirements
• Designs and develops complex programming algorithms
• Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; implements statistical methods not currently available through commercial software packages
• Thrives in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes
• Efficiently manipulates very large databases including complex data preprocessing, filtering, and manipulation
• Experience in CDISC and ADaM standards
• Demonstrated success in the assurance of deliverable quality and process compliance
• Strategic thinking – ability to analyze operational activities and challenges and develop and implement strategic solutions
• Ability to anticipate stakeholder requirements
• Ability and interest to work across cultures and geographies

Preferred Skills and Experience

• Experience with early oncology development
• Experience developing and implementing statistical programming standards
• Experience in process assessment, improvement and operational excellence methodologies
• Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
• Experience developing and managing a project plan using Microsoft Project or similar package
• Active in professional societies
• US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables
• Solid knowledge and experience on oncology clinical trial concepts and standards

Salary and Benefits

The salary range for this role is $173,200.00 - $272,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Equal Employment Opportunity

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights and EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado, and other US State Acts.