SimulStat Inc. Statistical Programmer (Remote) SimulStat Incorporated is a company that specializes in providing biostatistics and statistical programming services to the pharmaceutical and biotechnology industry. We’re looking for a dynamic, self-motivated Statistical Programmer with a thorough knowledge and experience in SAS Programming for Biotech/Pharma companies and validating SDTMs and ADaMs produced by CROs. If you’re looking to accelerate your career and join a team of passionate professionals, Simulstat is the place to be. What you will be doing ...

- Client has an urgent need for a statistical programmer with extensive validation experience. Will be validating SDTMs and ADaMs produced by CRO via independent programming - Must have extensive risk-based validation experience - Early development experience preferred - Review SDTM and ADaM specifications in details. Must be able to understand the protocol and SAP when reviewing the programming specifications. - Familiarity with clinical trial design and analysis activities. Strong knowledge of CDISC SDTM and ADaM data models - Strong SAS programming ski...

- Client has an urgent need for a statistical programmer with extensive validation experience. Will be validating SDTMs and ADaMs produced by CRO via independent programming - Must have extensive risk-based validation experience - Early development experience preferred - Review SDTM and ADaM specifications in details. Must be able to understand the protocol and SAP when reviewing the programming specifications. - Familiarity with clinical trial design and analysis activities. Strong knowledge of CDISC SDTM and ADaM data models - Strong SAS programming ski...

12 month remote renewable contract Top 3 Must Have Skill Sets: * SAS experience * Pharma industry experience * Statistical Analysis experience * Experience with claims databases (big plus) Work under the direction of Medical Affairs Statistics Disease Lead. • Actively provide statistical support to the Medical Affairs Department. • Provide statistical support for publications, presentations, posters at medical meetings and any other requests not covered in the clinical study report. This includes meta-analysis, multivariate analysis, use of graphical R an...

- Client has an urgent need for a statistical programmer with extensive validation experience. Will be validating SDTMs and ADaMs produced by CRO via independent programming - Must have extensive risk-based validation experience - Early development experience preferred - Review SDTM and ADaM specifications in details. Must be able to understand the protocol and SAP when reviewing the programming specifications. - Familiarity with clinical trial design and analysis activities. Strong knowledge of CDISC SDTM and ADaM data models - Strong SAS programming ski...

- Client has an urgent need for a statistical programmer with extensive validation experience. Will be validating SDTMs and ADaMs produced by CRO via independent programming - Must have extensive risk-based validation experience - Early development experience preferred - Review SDTM and ADaM specifications in details. Must be able to understand the protocol and SAP when reviewing the programming specifications. - Familiarity with clinical trial design and analysis activities. Strong knowledge of CDISC SDTM and ADaM data models - Strong SAS programming ski...

Our client, a growing bio-pharmaceutical company is hiring for their NYC office! The team is currently seeking a Clinical Trials Assistant (as a full time hire) to play a key role on a highly dynamic cross-functional team. Reporting to a Sr. Director of Clinical Operations, you will be responsible for support in the advancement of rare disease clinical trials as part of the company's Clinical Operations team from study start-up to study closure. Responsibilities: • In collaboration with Sr. Director Clinical Operations, support the study operational strat...

Senior Director of Quality Systems Compensation: Schedule: Full Time Position Summary: Under the direction of the Chief Medical Officer, the Quality Systems Senior Director is responsible for planning, coordinating and overseeing all of the functions within the scope of Quality Systems, including the Quality Control Program, Quality audits, Method/Instrument Validations, proficiency survey program, standard operating procedures, regulatory standards, and performance improvement/quality management monitors to ensure that services are of the highest quality...

SimulStat Incorporated is a company that specializes in providing biostatistics and statistical programming services to the pharmaceutical and biotechnology industry. We’re looking for a dynamic, self-motivated Statistical Senior Programmer with a thorough knowledge and experience in Biotech/Pharma to join our team in supporting Biostatisticians providing SAS programming for large databases and generating reports to enable analysts to explore real world healthcare data assets. If you’re looking to accelerate your career and join a team of passionate profe...

SimulStat Incorporated is a company that specializes in providing biostatistics and statistical programming services to the pharmaceutical and biotechnology industry. We’re looking for a dynamic, self-motivated Statistician with a thorough knowledge and experience in Biotech/Pharma to join our team in supporting our clients Medical Affairs Department, providing statistical analysis working with cross-functional teams including regulatory, clinical, marketing, data management and health economics. If you’re looking to accelerate your career and join a team...

TMF Manager (REMOTE) Temp-to-Perm As a member of the Clinical Program Operations team, the TMF Manager, will be the primary contact at Reata providing subject matter expertise and Clinical Operations Team support required to ensure that the Electronic Trial Master File (eTMF) and paper TMF is audit and inspection ready for current and past trials. The TMF Manager is also responsible for ensuring the TMF/eTMF is managed in accordance with relevant regulations, ICH-GCP guidelines and Reata SOPs. RESPONSIBILITIES: •Responsible for the maintenance and managem...

Our client, a bio-pharmaceutical company, is currently seeking a Clinical Trials Manager to play a key role on a highly dynamic cross-functional team. Reporting to a Sr. Director of Clinical Operations, you will be responsible for supporting the advancement of rare disease clinical trials as part of the Clinical Operations team. Key Roles and Responsibilities: • Support the study feasibility and site selection process and in conjunction with the Sr. Director Clinical Operations. • In collaboration with Sr. Director Clinical Operations, develop study opera...

establish the pricing and contracting strategy across channels including CDC, VFC, IDNs, Physician Buying Groups (PBGs), GPOs, Payers, Retail and other customers in the US. The role will collaborate with sales, legal, and brand teams to develop pricing and contracting strategies specific to the brand and assess and monitor the effectiveness of various channel and customer type pricing and contracting strategies. The role requires strong business acumen, deep knowledge of pricing and contracting, solid understanding of vaccine and/or buy and bill drugs, st...

- 12 month remote renewable contract Top 4 Must Have Skill Sets: * SAS experience * Pharma industry experience * Experience with claims databases * Statistical Analysis experience Work under the direction of Medical Affairs Statistics Disease Lead. • Actively provide statistical support to the Medical Affairs Department. • Provide statistical support for publications, presentations, posters at medical meetings and any other requests not covered in the clinical study report. This includes meta-analysis, multivariate analysis, use of graphical R and SAS too...

remote Epidemiology SAS programmer with leading pharmaceutical company: can do w2 hourly, corp to to corp or salary with paid days off??? the Care Pathways group and she has expressed that an ideal Care Pathways candidate would possess very strong SQL, MACRO, and claims data experience. A candidate with expenditure/cost analysis, code automation, and statistical analysis experience would be preferred. Although not required, a candidate with an MPH or Masters in Statistics is desired in lieu of graduate level in computer science...

oversee the progress of clinical monitoring by managing and conducting site evaluation, initiation, and interim close out visits to sites. Responsibilities Ensure data quality and compliance with protocol, SOPs, and regulations at assigned study sites. Monitor patient recruitment timelines at sites and report this information to assigned line manager. Assist with the arranging of study start-up meetings if necessary. Understand the device, protocol, and therapeutic area in sufficient detail to be able to advise and discuss with the study site personnel. C...

We are seeking AP/CP board certified Pathologist and are pleased to offer this exceptional opportunity in our rapidly growing hospital-based practice in Southern, IL. This practice will involve central practice in one hospital and support of other satellites hospitals. The successful candidate must be board certified in Anatomic and Clinical Pathology. Subspecialty training or certification is highly desired but not required. It is preferred that candidates currently hold Illinois medical license or be eligible. The position will have solo coverage and re...

Director of Molecular and Genomic Pathology Located near beautiful Port Chester, New York. Competitive salary and excellent benefits. Job Functions, Duties, Responsibilities and Position Qualifications: The Laboratory Director - you will ensure quality of testing while continuing to meet or exceed applicable regulatory standards. You are responsible for ensuring that the laboratory implements testing while consistently providing accurate and reliable patient NGS test results. Job Responsibilities: Essential Functions: Extensive experience in complex diagn...

Responsibilities Working in the Molecular Pathology department with a strong emphasis on Women's Health testing Carrying out HPV and STD testing Working with platforms such as SDA, real-time PCR, capillary electrophoresis, pyrosequencing, microarray technology and NGS. Assists supervisor with SOP's and regulatory requirements. Qualifications Bachelors of Science degree Must obtain a current Florida MT License Molecular Biology (additional licensure Microbiology, optional) MT ASCP or MB (ASCP) 3-5 years molecular pathology experience a must Candidate must ...

12 month remote renewable contract Top 4 Must Have Skill Sets: * SAS experience * Pharma industry experience * Experience with claims databases * Statistical Analysis experience Work under the direction of Medical Affairs Statistics Disease Lead. • Actively provide statistical support to the Medical Affairs Department. • Provide statistical support for publications, presentations, posters at medical meetings and any other requests not covered in the clinical study report. This includes meta-analysis, multivariate analysis, use of graphical R and SAS tools...

-12 month renewable remote contract Key Responsibilities Support targeted research of epidemiology of specific disease areas, including incidence/prevalence, BOI, and NH of disease for business development and early development indications Contribute to registry strategy for early development and early clinical indications to support BOI or NH of disease needed for regulators, payers, and clinicians Lead and execute evaluation of available registries and other data sources related to BOI or NH Determine potential use of RWE historical control within clini...

We are seeking an experienced Laboratory Sales Representatives with a proven track record in delivering results in the in the clinical testing market. Proven relationships and experience with onboarding: • Physician’s Offices (All Specialties) • Corporate Accounts • Clinical Laboratories We are currently seeking a motivated, experienced full-time Sales Representatives to engage explore markets and identify potential customers while promoting our testing services. We have established a state of the art clinical testing service. We are looking for a candida...

Our client, a biopharmaceutical company specializing in autoimmune and rare disease, is located in NYC. (The position is office based once things open up again in NYC.) They are currently looking for an experience Clinical Trial Manager, to join the Clinical Operations team! They are a terrific group of people and a stable environment providing growth and a career path for their team! Key Roles and Responsibilities: • Support the study feasibility and site selection process and in conjunction with the Sr. Director Clinical Operations. • In collaboration w...

- 12 month remote renewable contract At least 8 years of hands-on experience in Stat Programming, with no employment gaps. Note, positions mostly providing oversight of outsourced projects are not considered hands-on At least 4 years hands-on experience working on SDTM and ADaM data sets Hands-on experience in oncology and submissions (meaning, preparing metadata for a study and/or working on an ISS or ISE) Strong communication skills, both written and verbal Demonstrated attention to detail and focus on quality, supported by examples Demonstrated proacti...

KEY RESPONSIBILITIES include (not an exhaustive list of duties): Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget Monitor project resourcing, project budgets, and identify changes in scope Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards Maintain all supporti...

The Senior/Principal Biostatistician works independently in the production and quality control of analysis plans, reports, derived datasets, tables, listings and figures, provides statistical advice to clients and fulfills the project primary role within a designated project team. Key Accountabilities: Coordinate and lead a project team to successful completion of a project within timelines and budget Interact with clients as key contact with regard to statistical and contractual issues Perform QC of derived datasets, tables, figures and data listings pro...

Accountable for facility design/renovation, construction project management and the harmonization of facility engineering systems and maintenance and Health, Safety and Environmental procedures and practice to assure proper office accommodation, cleanroom manufacturing space, warehousing and a safe work environment in compliance with all state, federal, and regulatory governing agencies • Construction project management for facility design/renovation performed on time and on budget. • Engineering consultation on new facility projects at all sites. • Envir...

Director, Regulatory Affairs (FDA) Bergen County, NJ The Director US Regulatory Affairs supports the contract development and manufacturing of client cell therapy products for the US market. This individual collaborates cross-functionally to support client projects, including support for submissions, coordinating pre-approval inspections, and managing compliant licensing for all facilities supplying the US market. This individual also creates and maintains systems by which regulatory documentation is created, approved, submitted, and maintained. • Coordin...

Notes: Must be ABMG Board Certified MD Degree Prefer Cancer Genetics and Oncology Background Prior experience working directly with patients, seeing an average of 12 patients a day. Relocation assistance available. Responsibilities: Work closely with other members of the Division of Clinical Genetics (certified genetic counselors, genetic risk educator, patient scheduler, and administrative staff) to create a cohesive, effective, and productive clinical service worthy of a destination cancer center. Bring a medical perspective to the fundamental mission o...

100% Remote position- FTE. Must have excellent SAS and SQL experience, as well as extensive experience working with large, real world healthcare data. The senior programmer position will be responsible for manipulating large databases and generating reports using SAS to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS programming skills and the ability to implement complex data step logic. Candidates must be comfortable with creating complex analysis data sets derived from various data sources with a careful...

100% Remote position- FTE. Must have excellent SAS and SQL experience, as well as extensive experience working with large, real world healthcare data. The senior programmer position will be responsible for manipulating large databases and generating reports using SAS to enable analysts to explore real world healthcare data assets. Candidates must have excellent SAS programming skills and the ability to implement complex data step logic. Candidates must be comfortable with creating complex analysis data sets derived from various data sources with a careful...

We are currently looking for a Medical Director/ Senior Medical Director specializing in Oncology to join our client's global Medical Affairs team. We are open to Oncologists (board certified US or foreign board certified) who are interested in moving their career into industry, helping to develop and bring out new drugs for cancer patients. These positions are home-based with minimal travel, and can be based in either the US or Canada. Working in a fast-paced, client-focused global environment, our Medical Directors play a pivotal role on our client's pr...

We are currently looking for a Medical Director/ Senior Medical Director specializing in Oncology to join our client's global Medical Affairs team. We are open to Oncologists (board certified US or foreign board certified) who are interested in moving their career into industry, helping to develop and bring out new drugs for cancer patients. These positions are home-based with minimal travel, and can be based in either the US or Canada. Working in a fast-paced, client-focused global environment, our Medical Directors play a pivotal role on our client's pr...

We are currently looking for a Medical Director/ Senior Medical Director specializing in Oncology to join our client's global Medical Affairs team. We are open to Oncologists (board certified US or foreign board certified) who are interested in moving their career into industry, helping to develop and bring out new drugs for cancer patients. These positions are home-based with minimal travel, and can be based in either the US or Canada. Working in a fast-paced, client-focused global environment, our Medical Directors play a pivotal role on our client's pr...

As a FISH - Laboratory Supervisor, you will have the overall responsibility for the planning, coordination, evaluation, and supervision of all technical and/or operational activities and personnel in the department. You will be responsible for performing duties to meet quality assurance, safety and accreditation requirements in the laboratory. The FISH - Laboratory Supervisor is also responsible for helping in the implementation of all area procedures and operations as well as ensuring that metrics established to measure quality, production and efficiency...

12 month renewable contract - Remote - The minimum education requirement is a Master’s degree in Statistics, Biostatistics or other subject with high statistical content. - Min. 2 years of pharma/biotech experience with a PhD or 4 years with a master's degree - Experience in hematology, oncology or immunology therapeutic areas (at least one of those areas) - FDA or European regulatory experience and in-depth knowledge of regulatory regulations and guidelines. - Experience working on study protocol, study design, statistical analysis plans, and ad-hoc anal...

Flow Cytometry JOB openings in FL. The Flow Cytometry Technologist is responsible for daily specimen processing in the clinical flow cytometry laboratory. Communicates with staff physicians and other staff employees regarding patient specimens. Works with management personnel to ensure efficient and technically correct systems and procedures in the clinical cytometry laboratory that includes QA/QC of reagents, instrumentation, proficiency testing, etc. Qualifications Bachelor's Degree in Clinical Lab, Chemistry, Biology or related field and completed an a...

This position will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across specific programs. The ideal candidate will provide hands-on programming and validation support to project teams Essential Responsibilities: • Program analysis datasets, statistical tables, figures, and listings. • Generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation. • Provide statistical programming and validation support for clinical study reports and...

POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data management, clinical operations, biostatistics, and programming and will oversee the work of statistics and programming e...

The Senior Programmer is responsible for managing the inflow of a variety of healthcare claims and EMR databases, checking quality, developing specifications, transforming data to a common data model, and publishing data for use by statistical programmers, analysts and data scientists across the company. The qualified candidate must also be able to provide reports, presentations and detailed explanations to epidemiologists, analysts and programmers and work in collaboration with both internal and external partners. Prior experience with large databases an...

POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data management, clinical operations, biostatistics, and programming and will oversee the work of statistics and programming e...

• Provide statistical guidance, review, and contribution to SAPs; TFL shells; DMC Charters; SDF specifications (SDTM and ADaM); randomization specifications; other key-study related documentation, protocol deviations, data quality review, and other communications • Attend and be a contributor at Clinical Study Team Meetings • Attend meetings for and provide statistical input into cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review • Initia...

- 1 year renewable remote contract The Senior Programmer is responsible for managing the inflow of a variety of healthcare claims and EMR databases, checking quality, developing specifications, transforming data to a common data model, and publishing data for use by statistical programmers, analysts and data scientists across the company. The qualified candidate must also be able to provide reports, presentations and detailed explanations to epidemiologists, analysts and programmers and work in collaboration with both internal and external partners. Prior...

Remote Contract (W-2 or C2C)- 12 months Renewable- Sr. Biostatistician 1 year potentially renewable contract POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data management, ...

Remote Contract (W-2 or C2C)- 12 months Renewable- Sr. Biostatistician 1 year potentially renewable contract POSITION SUMMARY: The Senior Biostatistics Consultant role is responsible for statistical aspects of study design, for coordinating the analysis, validation, and study documentation, and for publication of data from all phases of studies. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, medical writing and especially with data management, ...

- 6 month renewable contract- Pharmaceutical Client - Remote - Required to work pacific hours Required Previous Experience Includes: *Oncology experience required Creation of datasets and Tables or QC of these outputs Both safety and efficacy (AE tables all types, Lab shift tables, Exposure tables, PFS, OS, DOR, ORR, TTE) Experience in generating figures (Kaplan Meier, forest plot, waterfall) SDTM, ADAM, SAS 9.4, BASE, ODS, SAS/STAT, SAS/GRAPH, SAS Macro...

Cytogenetic/FISH Technologist job openings in Tampa, Cape Coral FL/California/Nashville TN/Houston TX. - Preparation of clinical specimens (i.e. bone marrow, peripheral blood and lymph node) for cytogenetic testing, which include setting up the specimens, harvesting, slide making and banding - Screening the G banded slides - Setting up FISH for hematological probes. Washing and screening FISH slides. - Primary responsibilities of a technologist are focused on routine specimen analysis and reporting of results. - Provide overall assistance to the laborator...

Onsite - San Diego 12 month renewable contract Responsibilities will include, but are not limited to, the following: • Provide programming input to CRF, SAP, analysis file specifications, and tables, figures, and listings (TFLs) shells. • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. • Perform ad hoc flexible and rapid programming arising from questions generated from planned analyses and results. • Perform programming validation to ensure the quality of analysis datasets and programming outputs. • Ensure consistenc...

Long-term remote FSP - West-coast based (pacific or mountain time) * Min. 12 (ideally 15) years of statistical programming experience. * Prior experience leading/managing projects/people is critical * Must have extensive experience with Kaplan-Meierplots * Must have great communication skills, ability to work independently Responsibilities will include, but are not limited to, the following: • Write SAS programs to generate derived analysis datasets, perform analysis, and TFLs. • Perform ad hoc flexible and rapid programming arising from questions generat...

H1B transfer, stock, bonus, and relo. - Onsite San Diego - Min. 8 years of statistical programming experience in Pharma/Biotech _______________________________________________________________________ Function/Scope: As a Clinical Statistical Programming, you play a key role in developing, implementing and evaluating statistical programming standards and processes. You will be responsible for the production of selected project related Tables, Listings, and Figures (TLF), patient profiles, and integrated summaries of efficacy and safety data as required. Pr...