Data Analytics, Data science techniques, Design, Effective communication skills, Leadership Skill, Public Health, Python Programming, R Programming, SAS, Statistics
Position Summary: The Principal Statistical Programming Lead is a highly experienced Statistical Programmer with expert knowledge of Statistical Programming languages, tools and data structures, proven technical and analytic abilities and strong capabilities in leading Statistical Programming activities and programming teams in accordance to departmental processes and procedures.
This position is accountable for the planning, oversight and delivery of statistical programming activities in support of one or more clinical projects, compounds and/or submissions generally of high complexity/criticality. In addition, this position leads and/or contributes expert knowledge and technical skills to Therapeutic area and/or departmental innovation and process improvement projects.
In this role, the Principal Statistical Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams.
As highly experienced member of the Statistical Programming and Analysis team, they apply expert scientific, technical and problem-solving skills to ensure the operational effectiveness and efficiency of statistical programming activities across assigned projects and provide training or coaching to statistical programmers.
Principal Responsibilities:
As Programming Lead
• Accountable for Statistical Programming team delivery for 1 or more clinical projects of high complexity, scope and/or criticality.
• Provides matrix leadership to 1 or more programming teams, coordinating and overseeing programming team activities. May act as a section lead of programming activities supporting a clinical development program, compound or submission.
• Contributes to and applies strategic decisions and recommendations, developing and maintaining detailed programming strategy and plans.
• Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes.
• Performs comprehensive review of, and provides input into, project requirements and documentation.
• Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals.
• Independently manages interfaces and escalations with cross-functional project teams.
• As applicable, oversees statistical programming activities outsourced to third party vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality.
As a highly experienced Statistical Programmer;
• Designs and develops programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis request.
• Applies technical and analytical expertise to develop and implement solutions for use on clinical projects leading to increased efficiency and quality.
• Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental Technical groups and statistical programming portfolio leads.
Principal Relationships:
• Reports into people manager position within the Statistical Programming functional area. Accountable to the Statistical Programming TA Head and/or Statistical Programming Portfolio Lead for assigned programming activities and responsibilities.
• Functional contacts within IDAR may include but are not limited to Statistical Programming TA Head, Statistical Programming Portfolio Lead, Statistical Programmers, peer groups within department, IDAR Therapeutic Area Lead, Data Management and Clinical Data Standards, Regulatory Medical Writing.
• Functional contacts within Janssen (as collaborator or peer) include but are not limited to Trial Lead or equivalent, Quantitative Sciences, Biostatisticians, Regulatory, Clinical.
• External contacts include but are not limited to, external partners, CRO management and vendor liaisons, industry peers and working groups.
Qualifications
Preferred Experience
• Experience managing and overseeing the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g. Working with CROs, academic institutions).
Johnson & Johnson (J&J) is an American multinational corporation founded in 1886 that develops medical devices, pharmaceuticals, and consumer packaged goods. Its common stock is a component of the Dow Jones Industrial Average and the company is ranked No. 36 on the 2021 Fortune 500 list of the largest United States corporations by total revenue.
Schaffhausen, Switzerland
4-6 year
New Brunswick, NJ, USA
2-4 year
South San Francisco, CA, USA
2-4 year
Spring House, PA, USA
2-4 year
Titusville, NJ, USA
2-4 year
New Brunswick, NJ, USA
2-4 year
La Jolla, San Diego, CA, USA
2-4 year
Redwood City, CA, USA
2-4 year
Spring House, PA, USA
2-4 year
Titusville, Hopewell Township, NJ, USA
2-4 year
Spring House, PA, USA
0-2 year
Leiden, Netherlands
0-2 year
Beerse, Belgium
2-4 year
Titusville, Hopewell Township, NJ, USA
2-4 year
Spring House, Pennsylvania, USA
2-4 year
Titusville, Hopewell Township, NJ, USA
10-12 year
Cambridge, MA, USA
10-12 year
Beerse, Belgium
10-12 year
Irvine, CA, USA
4-6 year
Beerse, Belgium
2-4 year
Chiyoda, Tokyo, Japan
10-12 year
Spring House, PA, USA
2-4 year
Titusville, Red Oaks Mill, NY, USA
4-6 year
San Diego, CA, USA
4-6 year
South San Francisco, CA, USA
4-6 year
Spring House, PA, USA
4-6 year
San Diego, CA, USA
6-8 year
Horsham, Pennsylvania, USA
6-8 year
Chiyoda, Tokyo, Japan
8-10 year
Mumbai, Maharashtra, India
8-10 year
Bangalore, Karnataka, India
8-10 year
Hyderabad, Telangana, India
8-10 year
Mumbai, Maharashtra, India
4-6 year
Bangalore, Karnataka, India
4-6 year
Hyderabad, Telangana, India
4-6 year
Chiyoda, Tokyo, Japan
4-6 year
Mumbai, Maharashtra, India
8-10 year
Bangalore, Karnataka, India
8-10 year
Mumbai, Maharashtra, India
6-8 year
Bangalore, Karnataka, India
6-8 year
Hyderabad, Telangana, India
6-8 year
Titusville, Hopewell Township, NJ, USA
8-10 year
Bridgewater, NJ, USA
12-14 year
New Brunswick, NJ, USA
2-4 year
Tampa, FL, USA
2-4 year
Raritan, NJ, USA
2-4 year
Beerse, Antwerp, Belgium
4-6 year
Spring House, PA, USA
6-8 year
Horsham, PA, USA
8-10 year
Horsham, PA, USA
6-8 year
Titusville, Hopewell Township, NJ, USA
6-8 year
Leiden, South Holland, Netherlands
10-12 year
Breda, North Brabant, Netherlands
10-12 year
Rhein-Kreis Neuss, North Rhine-Westphalia, Germany
6-8 year
Leiden, South Holland, Netherlands
4-6 year
Dayton, Ohio, USA
2-4 year
Titusville, Hopewell Township, NJ, USA
10-12 year
Hyderabad, Telangana, India
6-8 year
Bangalore, Karnataka, India
6-8 year
Mumbai, Maharashtra, India
6-8 year
Hyderabad, Telangana, India
4-6 year
Bangalore, Karnataka, India
4-6 year
Mumbai, Maharashtra, India
4-6 year
South San Francisco, CA, USA
4-6 year
San Diego, CA, USA
4-6 year
Spring House, PA, USA
4-6 year
Titusville, Hopewell Township, NJ, USA
4-6 year
Brisbane, CA, USA
6-8 year
Cambridge, MA, USA
6-8 year
Spring House, PA, USA
6-8 year
Titusville, Hopewell Township, NJ, USA
4-6 year
Titusville, Hopewell Township, NJ, USA
4-6 year
Titusville, Hopewell Township, NJ, USA
4-6 year
Titusville, Hopewell Township, NJ, USA
4-6 year
Titusville, Hopewell Township, NJ, USA
6-8 year
Titusville, Hopewell Township, NJ, USA
4-6 year
Titusville, Hopewell Township, NJ, USA
8-10 year
Titusville, Hopewell Township, NJ, USA
6-8 year
Titusville, Hopewell Township, NJ, USA
8-10 year
Titusville, Hopewell Township, NJ, USA
4-6 year
Bridgewater, NJ, USA
8-10 year
Raritan, NJ, USA
8-10 year
Rhein-Kreis Neuss, Germany
0-2 year
New Brunswick, NJ, USA
4-6 year
Cambridge, MA, USA
4-6 year
Raritan, NJ, USA
4-6 year
Titusville, Hopewell Township, NJ, USA
4-6 year
Rhein-Kreis Neuss, North Rhine-Westphalia, Germany
2-4 year
Rhein-Kreis Neuss, North Rhine-Westphalia, Germany
2-4 year
High Wycombe, UK
2-4 year
Barcelona, Spain
2-4 year
Beerse, Antwerp, Belgium
2-4 year
North Rhine-Westphalia, Germany
2-4 year
Leiden, South Holland, Netherlands
2-4 year
Castile-La Mancha, Spain
2-4 year
Paris, Île-de-France, France
2-4 year
Zug, Switzerland
2-4 year
São Paulo, Brazil
4-6 year
Mexico City, CDMX, Mexico
4-6 year
Bogotá, Bogota, Colombia
4-6 year
Santiago, Chile
4-6 year
Titusville, Hopewell Township, NJ, USA
6-8 year
Mumbai, Maharashtra, India
10-12 year
Basel, Basel-City, Switzerland
6-8 year
Beerse, Antwerp, Belgium
6-8 year
Hyderabad, Telangana, India
10-12 year
Bangalore, Karnataka, India
10-12 year
Titusville, Hopewell Township, NJ, USA
4-6 year
Dallas, TX, USA; Rogers, AR, USA; West Chester, PA, USA; Memphis, TN, USA; Irving, TX, USA; San Angelo, TX, USA; Cincinnati, OH, USA; Somerset, NJ, USA; Titusville, Hopewell Township, NJ, USA; Piscataway, NJ, USA; Monument, CO, USA; Boston, MA, USA; Fremont, CA, USA; Cornelia, GA, USA; Palm Beach Gardens, FL, USA; Irvine, CA, USA; Jacksonville, FL, USA; Raynham, MA, USA; Athens, GA, USA; Horsham, PA, USA; Minneapolis, MN, USA; Malvern, PA, USA; Redwood City, CA, USA; Bridgewater, NJ, USA; New Brunswick, NJ, USA
0-2 year
Boston, MA, USA; Cambridge, MA, USA; Cincinnati, OH, USA; Irvine, CA, USA; Jacksonville, FL, USA; Raritan, NJ, USA; Raynham, MA, USA; Redwood City, CA, USA; San Diego, CA, USA; Santa Clara, CA, USA; Skillman, Montgomery, NJ, USA; Spring House, PA, USA; West Chester, PA, USA; Milpitas, CA, USA; Somerville, NJ, USA; Irving, TX, USA; Houston, TX, USA; Los Gatos, CA, USA; San Jose, CA, USA; Miami, FL, USA
0-2 year
Boston, MA, USA; Cambridge, MA, USA; Irvine, CA, USA; Jacksonville, FL, USA; Raritan, NJ, USA; Raynham, MA, USA; Redwood City, CA, USA; San Diego, CA, USA; Santa Clara, CA, USA; Skillman, Montgomery, NJ, USA; Spring House, PA, USA; West Chester, PA, USA; Milpitas, CA, USA; Somerville, NJ, USA; Warsaw, IN, USA; Irving, TX, USA; Houston, TX, USA; Los Gatos, CA, USA; San Jose, CA, USA; Miami, FL, USA
0-2 year
Bridgewater, NJ, USA; Cambridge, MA, USA; Fort Washington, PA, USA; Horsham, PA, USA; New Brunswick, NJ, USA; Piscataway, NJ, USA; Providence, RI, USA; Raritan, NJ, USA; San Diego, CA, USA; Skillman, Montgomery, NJ, USA; Somerset, NJ, USA; Somerville, NJ, USA; Spring House, PA, USA; Tampa, FL, USA; Titusville, Hopewell Township, NJ, USA; West Chester, PA, USA
10-12 year
Bridgewater, NJ, USA; Cambridge, MA, USA; Fort Washington, PA, USA; Horsham, PA, USA; New Brunswick, NJ, USA; Piscataway, NJ, USA; Providence, RI, USA; Raritan, NJ, USA; San Diego, CA, USA; Skillman, Montgomery, NJ, USA; Somerset, NJ, USA; Somerville, NJ, USA; Spring House, PA, USA; Tampa, FL, USA; Titusville, Hopewell Township, NJ, USA; West Chester, PA, USA
0-2 year
Bridgewater, NJ, USA; Cambridge, MA, USA; Fort Washington, PA, USA; Horsham, PA, USA; New Brunswick, NJ, USA; Piscataway, NJ, USA; Providence, RI, USA; Raritan, NJ, USA; San Diego, CA, USA; Skillman, Montgomery, NJ, USA; Somerset, NJ, USA; Somerville, NJ, USA; Spring House, PA, USA; Tampa, Florida, USA; Titusville, Hopewell Township, NJ, USA; West Chester, PA, USA
0-2 year
Bridgewater, NJ, USA; Fort Washington, PA, USA; Horsham, PA, USA; New Brunswick, NJ, USA; Piscataway, NJ, USA; Providence, RI, USA; Raritan, NJ, USA; San Diego, CA, USA; Skillman, Montgomery, NJ, USA; Somerset, NJ, USA; Somerville, NJ, USA; Spring House, PA, USA; Tampa, FL, USA; Titusville, Hopewell Township, NJ, USA; West Chester, PA, USA
0-2 year
Cambridge, MA, USA; Cincinnati, OH, USA; Horsham, PA, USA; New Brunswick, NJ, USA; Raritan, NJ, USA; Redwood City, CA, USA; Santa Clara, CA, USA; Skillman, Montgomery, NJ, USA; Spring House, PA, USA; Tampa, FL, USA; Titusville, Hopewell Township, NJ, USA
2-4 year
Boston, MA, USA; Brisbane, CA, USA; Cambridge, MA, USA; Horsham, PA, USA; La Jolla, San Diego, CA, USA; New Brunswick, NJ, USA; Raritan, NJ, USA; San Diego, CA, USA; South San Francisco, CA, USA; Spring House, PA, USA; Titusville, Red Oaks Mill, NY, USA
2-4 year
Boston, MA, USA; Brisbane, CA, USA; Cambridge, MA, USA; Horsham, PA, USA; La Jolla, San Diego, CA, USA; New Brunswick, NJ, USA; Raritan, NJ, USA; San Diego, CA, USA; South San Francisco, CA, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
4-6 year
Horsham, PA, USA; Raritan, NY, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
6-8 year
Athens, GA, USA; Cornelia, GA, USA; Guaynabo, PR, USA; Gurabo, PR, USA; Jacksonville, FL, USA; Raritan, NJ, USA; Raynham, MA, USA; San Lorenzo, PR, USA; West Chester, PA, USA
4-6 year
Madrid, Spain; Toledo, Spain
0-2 year
Berlin, Germany; Neuss, Germany
0-2 year
La Jolla, San Diego, CA, USA; Spring House, PA, USA
0-2 year
Buckinghamshire, UK
0-2 year
Bridgewater, NJ, USA; Cambridge, MA, USA; Horsham, PA, USA; La Jolla, San Diego, CA, USA; New Brunswick, NJ, USA; Raritan, NJ, USA; Spring House, PA, USA; Tampa, FL, USA; Titusville, Hopewell Township, NJ, USA
2-4 year
Cambridge, MA, USA; New York, NY, USA; Raritan, NJ, USA; San Diego, CA, USA; South San Francisco, CA, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
2-4 year
Cambridge, MA, USA; New York, NY, USA; Raritan, NJ, USA; San Diego, CA, USA; South San Francisco, CA, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
4-6 year
Cambridge, MA, USA; New York, NY, USA; Raritan, NJ, USA; San Diego, CA, USA; South San Francisco, CA, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
0-2 year
Cambridge, MA, USA; New York, NY, USA; Raritan, NJ, USA; San Diego, CA, USA; South San Francisco, CA, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
10-12 year
Boston, MA, USA; La Jolla, San Diego, CA, USA; New Brunswick, NJ, USA; Raritan, NJ, USA; South San Francisco, CA, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
4-6 year
Cambridge, MA, USA; La Jolla, San Diego, CA, USA; New York, NY, USA; Raritan, NJ, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
0-2 year
Cincinnati, OH, USA; Irvine, CA, USA; Palm Beach, FL, USA; Raynham, MA, USA; Warsaw, IN, USA; West Chester, PA, USA
4-6 year
Beerse, Antwerp, Belgium
2-4 year
Cambridge, MA, USA; Raritan, NJ, USA; South San Francisco, CA, USA; Spring House, Pennsylvania, USA; Titusville, Hopewell Township, NJ, USA
2-4 year
Cambridge, MA, USA; La Jolla, San Diego, CA, USA; New York, NY, USA; Raritan, NJ, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
0-2 year
Beerse, Antwerp, Belgium
8-10 year
Cambridge, MA, USA; La Jolla, San Diego, CA, USA; New York, NY, USA; Raritan, NJ, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
8-10 year
Boston, MA, USA; New Brunswick, NJ, USA; Raritan, NJ, USA; San Diego, CA, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
8-10 year
Boston, MA, USA; New Brunswick, NJ, USA; Raritan, NJ, USA; San Diego, CA, USA; South San Francisco, CA, USA; Titusville, Hopewell Township, NJ, USA
2-4 year
New Brunswick, NJ, USA; Raritan, NJ, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA; United States
6-8 year
Bridgewater, NJ, USA; Irvine, CA, USA; Jacksonville, FL, USA; New Brunswick, NJ, USA; Seattle, WA, USA; Tampa, FL, USA; Titusville, Hopewell Township, NJ, USA
4-6 year
Beerse, Antwerp, Belgium
2-4 year
Cambridge, MA, USA; New York, NY, USA; Raritan, NJ, USA; San Diego, CA, USA; South San Francisco, CA, USA; Spring House, Pennsylvania, USA; Titusville, Hopewell Township, NJ, USA
2-4 year
Cincinnati, OH, USA; Horsham, PA, USA; New Brunswick, NJ, USA; Palm Beach Gardens, FL, USA; Raynham, MA, USA; Titusville, Hopewell Township, NJ, USA; West Chester, PA, USA
8-10 year
Beerse, Antwerp, Belgium
2-4 year
Cambridge, MA, USA; Raritan, NJ, USA; San Diego, CA, USA; South San Francisco, CA, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
2-4 year
Cambridge, MA, USA; San Diego, CA, USA; South San Francisco, CA, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
2-4 year
Boston, MA, USA; Brisbane, CA, USA; Cambridge, MA, USA; New Brunswick, NJ, USA; South San Francisco, CA, USA
4-6 year
Boston, MA, USA; San Diego, CA, USA; South San Francisco, CA, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
4-6 year
New Brunswick, NJ, USA; Raritan, NJ, USA; Spring House, PA, USA; Titusville, Hopewell Township, NJ, USA
4-6 year
Irvine, CA, USA; New Brunswick, NJ, USA; Raritan, NJ, USA
6-8 year
Horsham, PA, USA; La Jolla, San Diego, CA, USA; Raritan, NJ, USA; Titusville, Hopewell Township, NJ, USA
0-2 year
Cambridge, MA, USA; San Diego, CA, USA; South San Francisco, CA, USA; Spring House, PA, USA
6-8 year
Irvine, CA, USA; Jacksonville, FL, USA; Milpitas, CA, USA
6-8 year