ClinChoice
Position: Principal Biostatistician
Employment type: Full Time
Location: Fort Washington, PA/Remote
About FMD K&L
FMD K&L is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our Customers. K&L was established in the US in 1995, and has grown to more than 1,700 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region. Please visit our website klserv.com for our company information. If you are interested in our position, please send your resume to FMDKL-Career@klserv.com.
Duties & Responsibilities:
- Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
- Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
- Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
- Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
- Responsible for validity of analysis and explore alternative analysis strategies as needed.
- Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
- Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
- Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
- Effectively mentor peers with regards to statistical methodology and provide appropriate training to less experienced statisticians.
- Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.
Requirements:
- MS or PhD in Statistics, Biostatistics or related field. PhD with 3-5 years of experience or MS with 6-8 years of experience.
- Strong oral and written communications skills, with ability to effectively communicate internally and with clients.
- Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
- Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.
FMD K&L is an Equal Opportunity Employer / Committed to Diversity
Contact:
Please send your resume to Xiaohua.Sheng@klserv.com.
Position: Senior Biostatistician
Employment type: Full time
Location: Fort Washington, PA/Remote
About FMD K&L
FMD K&L is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our Customers. K&L was established in the US in 1995, and has grown to more than 1,700 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region. Please visit our website klserv.com for our company information. If you are interested in our position, please send your resume to FMDKL-Career@klserv.com.
Duties & Responsibilities:
The Senior Biostatistician serves a lead role on projects. He/she interacts with team members in designing and analyzing clinical trials. Key responsibilities and skills include, but are not limited to:
- Responsible for protocol development including study design, sample size estimation, randomization, and statistical analysis plan for assigned studies.
- Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
- Responsible for accuracy and completeness of database quality checks.
- Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
- Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
- Responsible for validity of analysis and alternative analysis strategies when unforeseen circumstances arise.
- Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
- Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
- Responsible for statistical methods section for the reports. Identifies and corrects flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
- Effectively mentor non-statistical peers with regards to statistical methodology and provide appropriate background, motivation, and training to junior statisticians.
- Effectively coordinate assignments and review deliverables so that projects are delivered on time with high quality.
Requirements:
- MS or PhD in Statistics, Biostatistics or related field. Ph.D. with 2+ years of experience or MS with 4+ years of experience.
- High degree of technical competence and communication skill, both oral and written.
- Competent in experimental design, descriptive and inferential statistics.
- Pharmaceutical, CRO, or related industry experience with clinical trials.
FMD K&L is an Equal Opportunity Employer / Committed to Diversity
Contact:
Please send your resume to Xiaohua.Sheng@klserv.com.
Position: Principal Statistical Programmer/Lead
Location: Fort Washington, PA/Remote
Employment type: Full time
This is an advanced Principal Programmer Analyst or Lead/Manager level position. Key responsibilities and skills may include, but are not limited to:
- Programming edit checks for Data Management with SAS.
- Create tables, listings and figures for clinical study report.
- Independently annotated blank CRF (acrf.pdf) with appropriate tools per FDA or CDISC guidelines.
- Create or QC SDTM specifications and SDTM datasets.
- Create or QC ADaM specifications and ADaM datasets.
- Create or QC define.xml or define.pdf.
- Create Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf).
- Serve as Team Leader for the Programming group.
- Independently coordinate and manage the preparation, execution, reporting and documentation of projects within a programming group.
- Manage and coordinate the integration of data across studies in support if ISS and ISE and electronic submission deliverables.
- For Manager, manage Programming team. Take initiatives and follow through to develop the Programming team. Dare to lead.
- Be a role model
Qualifications
- Bachelor’s degree in computer science, statistics or related scientific disciplines with 7+ year clinical programming experience; Master’s degree in computer science, statistics or related disciplines with 6+8 year of clinical programming experience.
- Working knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
- Good understanding of clinical drug development process
FMD K&L is an Equal Opportunity Employer / Committed to Diversity
Contact:
Please send your resume to Xiaohua.Sheng@klserv.com.
Position: Senior Statistical Programmer Analyst
Employment type: Full time
Location: Fort Washington, PA
About FMD K&L
FMD K&L is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our Customers. K&L was established in the US in 1995, and has grown to more than 1,700 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region. Please visit our website klserv.com for our company information. If you are interested in our position please send your resume to FMDKL-Career@klserv.com
Responsibilities
This is an advanced-level Senior Programmer Analyst position. Key responsibilities and skills may include, but are not limited to:
- Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines;
- Independently create tables, listings and figures for clinical study reports with no supervision;
- Independently create or validate SDTM specifications and SDTM datasets with no supervision;
- Create or validate ADaM specifications with reasonable supervision;
- Create or validate ADaM datasets with no supervision;
- Create FDA submission package, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision;
- Proficiently gather information and decipher programming logics;
- Actively communicate with statisticians for statistical input and analysis interpretation;
- Follow and reinforce regulatory agency requirements during daily job function;
- Serve as a mentor for junior team members and provide technical guidance;
- Serve as a programming team lead and contribute to department initiatives.
Qualifications
- Bachelor’s/Master’s degree in Statistics, Computer Science, Electrical and Computer Engineering, Biotechnology or related scientific disciplines with at least 3 years of clinical programming experience;
- Proven knowledge and training in high level computing languages such as SAS, C++, Java, R, Python, and/or Pearl. Database programming experience is a plus;
- Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members;
- Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world;
- In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology;
- Good understanding of clinical drug development process;
- Strong communication skills and coordination skills; ability to communicate with global teams with supervision;
- Detail-oriented and ability to learn and adapt to changes;
- Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.
FMD K&L is an Equal Opportunity Employer / Committed to Diversity.
Contact:
Please send your resume to Xiaohua.Sheng@klserv.com.
Position: Statistical Programmer Analyst III
Employment type: Full time
Location: Fort Washington, PA
About FMD K&L
FMD K&L is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our Customers. K&L was established in the US in 1995, and has grown to more than 1,700 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region. Please visit our website klserv.com for our company information. If you are interested in our position please send your resume to FMDKL-Career@klserv.com
Responsibilities
This is a mid-level programmer analyst position. Key responsibilities and skills may include, but are not limited to:
Independently develop SAS programs to create SDTM datasets following CDISC SDTM standard;
Develop SDTM specifications for programming;
Independently create development and validation programs for ADaM datasets by SAS programming following ADaM specifications;
Develop ADaM analysis data specifications for programming with minimum supervision;
Develop, debug, maintain, and produce SAS programs used in creating tables, listings and figures for clinical study report following CDISC and industry guidelines and study analysis plan;
Independently Implement SAS programs to generate Define-XML package;
Programming complicated edit checks for Data Management with SAS;
Implement data analysis using SAS programming and communicate with statisticians for statistical input;
Perform data manipulation programming techniques and implement SAS macros to facilitate table, listing and figure generation and verification;
Perform other programming tasks as needed per management requests;
Provide support and coordination of well-defined programming projects.
Qualifications
Bachelor’s/Master’s degree in Statistics, Computer Science, Electrical and Computer Engineering, Biotechnology or related scientific disciplines with 2+ years of statistical programming experience required;
Proven knowledge and training in high level computing languages such as SAS, C++, Java, R, Python, and/or Pearl. Database programming experience is a plus;
Ability to translate statistical analysis plan into SAS programming language, to update and fix existing programs;
Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology;
Good understanding of clinical drug development process;
Team player, strong communication skills and coordination skills;
Detail oriented and ability to learn and adapt to changes;
Proficient in Microsoft Office Suite, e.g. Word, Excel, PowerPoint, etc.
FMD K&L is an Equal Opportunity Employer / Committed to Diversity
Contact:
Please send your resume to Xiaohua.Sheng@klserv.com.
Job Title: Data Manager
Employment Type: Full Time
Location: Fort Washington, PA
Reporting to: Senior Manager, Data Management
About FMD K&L
Job Title: Data Manager Employment Type: Full Time Location: Fort Washington, PA
Reporting to: Senior Manager, Data Management
About FMD K&L
FMD K&L is a global contract research organization supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide.
We continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our Customers. K&L was established in the US in 1995, and has grown to more than 1,400 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region.
Data Management Services
The Data Manager will be responsible for leading data management (DM) activities for clinical trials including database set-up, study conduct and close-out. The Data Manager will work collaboratively with a cross functional team to maintain project timelines and to deliver high quality DM deliverables.
Key responsibilities may include, but are not limited to:
- Lead Data Management activities and ensure study deliverables meet timelines and quality standards.
- Review of Clinical research documents (e.g., Protocols, Case Report Forms).
- Create and review electronic Case Report Form (eCRF) specifications.
- Develop critical DM documents such as the Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Data Entry Guidelines and Data Review Plan.
- Develop edit rules/checks, query logic and query messages.
- Develop User Acceptance Testing Plan and perform testing on data entry screens and edit checks.
- Create and provide training to the clinical team and sites.
- Perform ongoing data review/reconciliation activities and provide metrics and patient trackers to monitor data clean up.
- Perform database lock/unlock and freeze/unfreeze activities as appropriate for statistical review, interim analysis, and final database lock.
- Coordinate the archiving of study databases and related documents.
- Create Data Transfer Specifications and perform external vendor reconciliation.
- Perform SAE reconciliation.
- Work to maintain/improve client satisfaction by ensuring high quality service, communication and management of clinical data.
Essential Skills Required & Education:
- Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field or nursing degree.
- At least 3 years data management and/or related work experience in a medical device or pharmaceutical industry/company is preferred.
- Working knowledge of Clinical research and Clinical trial process and related regulatory requirements and terminology.
- Strong knowledge and experience in several Electronic Data Capture systems such as Medidata Rave, Oracle InForm, OpenClinica and Medrio.
- Perform duties in compliance with SOPs, Good Clinical Practices and ICH guidelines.
- Ability to prioritize and to adapt quickly in fast-paced and changing industry conditions.
- Ability to lead a study or data management team independently.
- Proactively drive quality and efficiency to meet timelines and milestones to deliver high quality data management deliverables.
- Excellent verbal and written communication skills.
- Proficient in the use of Microsoft Office (Outlook, Word, Excel, PowerPoint, etc.).
- Oncology experience is preferred.
FMD K&L is an Equal Opportunity Employer / Committed to Diversity.
Contact:
Please send your resume to Xiaohua.Sheng@klserv.com.