142 Pharmaceutical jobs

Smith Hanley Associates Senior Biostatistician Washington DC area Nihar Parikh, nparikh@smithhanley.com Our client has an opening for an experienced Biostatistician to provide statistical expertise, clinical trial design, and data analysis for clinical studies within multiple therapeutic areas. Responsibilities: -Oversee clinical development plans, SAP, and study design. -Support protocol development and provide strategic guidance for global project teams. -Lead regulatory submissions, provide regulatory strategy and interact with the FDA. -Support clinical study report writing and clinical publications. -Apply statistical principles and provide solutions to problems in drug research. -Provide statistical oversight to vendors, mentor staff and work with cross-functional teams. Qualifications: -MS/PhD in Biostatistics, Mathematics, or related field and 5+ years of experience in Pharma/Biotech. -Background in Cardiovascular, Oncology, Respiratory, Diseases or similar therapeutic area. -Experience in regulatory submissions, clinical development and statistical analysis plans. -Experience in program design, clinical study reports, statistical protocol and regulatory interactions. -Experience in SAS/R programming. -Strong interpersonal and communication skills. www.smithhanley.com

Smith Hanley Associates Senior/Principal Statistical Programmer Washington DC area Nihar Parikh - nparikh@smithhanley.com In this role you will provide statistical programming support for drug products including analysis and reporting, clinical studies, regulatory submissions, commercialization, and technical standards. Responsibilities: -Oversee quality of deliverables and support clinical development plans, regulatory submissions, data reporting, and Oncology projects. -Deliver clinical study reports, SDTM/RDB databases as well as tables, listings and figures results. -Provide statistical programming, analysis and reporting, as well as information infrastructure and statistical methodologies. -Maintain technical database standards and programming specification documents. -Develop best practices, monitor safety/efficacy of data, and implement innovative solutions. Qualifications: -Bachelor's/Master's Degree in Statistics, Math, Computer Science or related discipline. -Experience in pharma required. Background in Oncology, Respiratory, or similar therapeutic area. -Experience in clinical drug development, regulatory requirements, CDISC standards, and data submission. -Experience in statistical programming, report publishing, and the ability to define business processes. -Strong SAS programming; Exposure to R, SQL, etc. a plus. www.smithhanley.com #GD

Title: Oncology Sales Account Representative Location: Bronx, NY Company:TOP Biotech Company Compensation: $135K-$160k Base +$35K Target Bonus + Stocks +Amazing Benefits Contact: Nancy Ragonese- nragonese@smithhanley.com; Tel. 203 319-4315 Exciting Opportunity for Impact and Growth in ONCOLOGY at a TOP GLOBAL Biotech Company! ***Please Note: If you apply and do not meet the below requirements you will not be contacted or considered*** REQUIRED: -Currently working in Pharmaceutical Sales and in Oncology! -1 or more years' experience in Oncology is required -Documented sales results depicting significant success, including examples of national awards for performance, company awards, or participation in management development program are preferred -Residence within the current geography is required- Territory is Bronx to Westchester -4 year Bachelor's degree from an accredited University required

Title: Regional Account Manager Location: NYC/ Long Island Company: Top Biotech Company Compensation: $150K-$165K Base + $40K Uncapped Bonus + Car + Excellent Benefits! Contact: Nancy Ragonese- nragonese@smithhanley.com ***Serious Inquiries Only: If you apply and do not meet the below requirements you will not be contacted or considered*** AMAZING GROUND FLOOR OPPORTUNITY AT A SMALL BIOTECH! * Candidate must be currently in a Key Account Manager/ Regional Account Manager role in Pharma/Biotech for the past 2 years where IDN's are your targets and you have experience with contracting and GPO's ! *NOT a Sales Rep job- this role equates to District Manager level * Must have experience working closely with C-Suite and Population Health decision makers *Experience developing strategic pricing proposals/ contracts * At least 8 years total experience in the Pharmaceutical/Biotech Industry * Lives within the Territory- NYC/ Long Island and has connections with VP/Director Supply Chain within the health systems in the territory: Northwell, Mount Sinai, NY Presbyterian Email your resume or referral to: nragonese@smithhanley.com

Title- Manager/Sr. Consultant, Commercial Analytics-PHARMA Location-Greater Boston (prefers), but also NYC or NJ Salary -$110-130k + bonus Consultant- Eda Zullo, ezullo@smithhanley.com My client, a boutique PHARMA/Healthcare Analytics Vendor, is seeking a "Manager/Sr. Consultant, Commercial Analytics" Professional! In this role you will be supporting their clients with data and analytics. You will be client point person! Responsibilities- *will lead client engagements-that focuses on data solutions * lead a team that supports projects-in commercial data, reporting and analytics *setting timelines and implementing the strategy for delivery *partner with the leadership team on business development opportunities Requirements .* BS or MS in STEM -Science, Mathematics, Engineering, Statistics * 5-8 years of PHARMA Commercial Analytics * Able to develop strong business relationships. *Experience with sales data . (IMS, Symphony Health, claims, EMR) required *Tableau and SQL STRONGLY preferred

Title-Associate Director, Forecasting -PHARMA Location- Greater Atlanta, GA (relo provided) Salary-$160-170k + bonus Consultant- Eda Zullo, ezullo@smthhanley.com My client, a GLOBAL Pharma Company, us seeking an "Associate Director, Forecasting-PHARMA" Professional! In this role you will be responsible for *Being the SME and key business partner for delivering forecasts and analytics to the commercial business team leaders *Leading/performing ad hoc analytics in support of forecasting insights. Will ensure appropriate data is utilized in forecast modelling, oversee and execute forecast models *Performing complex data analysis *Forecasting methodologies including Time-Series analysis, TRx-based modelling, Patient-based modelling, selection and application of Analogs and incorporation of primary market research approaches *Developing analytic assessments of key factors that will impact revenue streams; such as changes to government policy, changes to the Healthcare ecosystem, and advances in Technology *Collaborating with the business units to develop reports efficiently and effectively to meet information needs of sales, marketing, and operations management Requirements: *BA degree, Masters is desired in Math, Statistics or other Quantitative area *8+ years' experience working in an advanced analyst role preferred *5+ Years of demonstrated success in analysis and forecast modelling *Experience working with prescription data, longitudinal patient data, and managed care data-MMIT, formulary, etc. *Experience in statistical techniques i.e. linear regression, logistic regression, decision tree, machine learning methods and time series forecasting techniques such as ARIMA, exponential smoothing *Experience in using test-control techniques for resource allocation. *Must be able to present data to senior leadership *Ability to travel ~ 15%

Title: Specialty Sales Representative- Cardiovascular Location:Manhattan, NY Company: Top Global Pharmaceutical Company Compensation: $70K base +$10K Target Bonus +$450 monthly car allowance Contact: Nancy Ragonese- nragonese@smithhanley.com Exciting Opportunity in Specialty Cardio for Impact, Growth and Exposure at a TOP GLOBAL Pharma Company! ***Please Note: If you apply and do not meet the below requirements you will not be contacted or considered*** * Candidate must be currently in Pharmaceutical Sales for at least 1-2 years (no entry level candidates considered) * Dermatology experience preferred * Lives within the Territory: Manhattan. This is a "walkable" territory! Email your resume or referral to: nragonese@smithhanley.com

Title-Senior Manager, Incentive Comp Lead-PHARMA Location- Greater Los Angeles, CA (relo provided) Salary-Depends on Experience Consultant- Eda Zullo, ezullo@smithhanley.com My client, a BIG BIOPHARMA Company, is seeking a "Senior Manager, Incentive Compensation Lead" EXPERT! In this role you will be responsible for- *designing and implementing incentive comp plans and goals *manage IC plan and payouts *Rolling out IC plans to field/sales staff *always monitor the IC plan on successes and problems *Being the strategic partner with the Business Leadership and managing the analytics *responsible for payouts and field inquiries Requirements- *BA degree/ MA degree desired -with 4-6 years sales ops and data analytics experience 3+ yrs. of IC Design and administration, data management *7+ years of analyzing data *5+yrs of sales ops/IC *Strong knowledge of data- IMD DD, Xponent data, etc. *Extremely strategic and has the ability to work and present to senior leadership

Title- Director, Global Forecasting-PHARMA Location - Greater Los Angeles, CA (relo provided) Salary- Depends on Experience Consultant- Eda Zullo, ezullo@smithhanley.com #GD My client, a GLOBAL PHARMA Company, is seeking a "Director, Global Forecasting" Professional. Responsibilities o Develop the forecast models based on assumptions and in collaboration with global marketing and strategy teams o Lead partnership with brand leadership with regional forecasting teams who provide data for the forecast o Perform analyses of market size, penetration, market dynamics, etc that lead to global forecasts o Ensure translation of key insights, patient journey and other critical information into product forecasts o Ensure implementation, collaboration and communication of global forecasts to all key functions and regions impacted by the forecast o Present forecasts to product strategy teams, review boards and senior management Requirements *BA or MA degree *7-10 years of PHARMA forecasting and/or analytics experience * Experience with quantitative techniques including smoothing, regression, time series analysis, and simulation *Strong project management skills-able to organize and complete multiple projects efficiently and on time *Strong understanding of global markets

Smith Hanley Associates Director/Senior Director, Statistical Programming Washington DC area Nihar Parikh - nparikh@smithhanley.com Exciting leadership opportunity to join a global biopharma and oversee a team with statistical programming, regulatory submissions, data standards, clinical drug development, and foster decision making. Responsibilities: -Direct programming projects and manage a team. -Oversee quality of deliverables and lead clinical development plans, regulatory submissions, and data collection. -Manage clinical development programming, analysis and reporting, as well as information infrastructure. -Implement best practices, develop strategies, and improve statistical methodologies within drug projects. -Duties include standards development and technical guidance to meet business objectives. Qualifications: -Bachelor's/Master's Degree in Statistics, Math, Computer Science or related discipline. -Proven leader in pharma or healthcare with knowledge of CDISC standards such as CDASH, SDTM, ADaM, etc. -Experience in statistical programming within clinical drug development. -Strong SAS expertise and a background in Diabetes, Oncology, Respiratory, or similar therapeutic area. -Experience in NDA/BLA regulatory submissions and good clinical practice. -Strong technical knowledge and people management background. #GD Smith Hanley is a niche recruiting agency. To view our jobs, please go to http://jobs.smithhanley.com/

Smith Hanley Associates VP Biostatistics & Data Management Greater New York area Nihar Parikh - nparikh@smithhanley.com Exciting opportunity for a leader to join a global biopharma in rare diseases and be part of a product launch. This is a high visibility role with responsibilities overseeing the statistical and data management function. Responsibilities: -Manage a team and provide technical leadership in designing and analyzing clinical trials. -Review sample size estimation and statistical protocols. -Oversee drug development projects, statistical analysis plans, regulatory submissions, and study design. -Lead data collection, clinical data management, statistical reporting and creation of CDISC datasets. -Analyze data, interpret results for publications and provide strategic guidance. -Work with senior leadership and cross functional teams including CRO's, Medical/Regulatory Affairs, Clinical Scientists and Data Management. Qualifications: -PhD in Biostatistics, Math, Computer Science or related discipline with 15 or more years of experience in biostatistics and statistical programming. -Proven leader in pharma or biotech. Background in Autoimmune, Orphan or Rare Diseases a plus. -Experience in NDA regulatory submissions, statistical analysis plans, clinical trials design and strong statistical methodology. -Experience with regulatory agencies, statistical planning, strategy guidance and publications. -Strong proficiency in SAS. -Experience with clinical data management and CDISC standards. -Strong people management background and exceptional communication skills. Smith Hanley is a niche recruiting agency. To view our jobs, please go to http://jobs.smithhanley.com/

Smith Hanley Associates Manager, Statistical Programming Greater Chicago area $100k - $125k salary range Nihar Parikh - nparikh@smithhanley.com Responsibilities: -Statistical programming to produce analysis, reports, and graphs on the company's drugs in the clinical phase. -Supervise programmers and analyze clinical data. -Review programming codes and work with the statistical computing team to increase efficiency. -Manage statistical programming function, establish output standards and system processes. Qualifications: -Bachelor's/Master's Degree in Statistics, Math, Computer Science or related discipline. -5+ years of experience with statistical programming, generating analysis and reports. -Strong SAS programming and a background in pharma or healthcare. -Experience in clinical drug development, regulatory requirements, and data submission standards. #GD Smith Hanley is a niche recruiting agency. To view our jobs, please go to http://jobs.smithhanley.com/

Title- Sr. Mgr., Commercial Data Management/Data Governance-PHARMA Location - Central NJ Salary- $140- 155k + 15% bonus Consultant- Eda Zullo, ezullo@smithhanley.com #GD My client, a mid size PHARMA company, is seeking a "Senior Manager, Commercial Data Management/Data Governance-PHARMA" professional! Main Function *Lead data governance meetings to negotiate and gain approval of data issue resolution, metric definitions, metadata and policies. *Lead and deliver solutions that cut through multiple data processes *Define and Govern rules for data values and structure, and user access *Manage and track required third-party data access agreements. *Business lead for Payer/Contract/Formulary Master data management, Reference data management and Market Access/contracting/pricing Data Mart capabilities. Requirements *BA degree MA desired *10+ yrs. in the Pharma industry *6 + yrs. of demonstrated data project management/ MDM *Deep understanding of pharma data (IMS, Rebates, Payer spine, Contracting, ModelN, MMIT, SP Pharmacy & Hub Model, etc). *Technically independent to drive efficiency in the management of data assets.

Smith Hanley Associates Director, Biostatistics - Oncology Washington DC area Nihar Parikh - nparikh@smithhanley.com In this role you will lead clinical development plans, regulatory submissions, statistical methodology, and strategic guidance for various drug products. Responsibilities: -Lead statisticians within the Oncology team on program design, clinical product development, and strategic initiatives. -Statistical work standardization within product compliance. -Provide leadership across projects/indications and implement statistical approaches for value demonstration and regulatory guidance. -Maintain relationships with collaborative groups, consultants, and organization leaders. -Oversee CRO and other partners on deliverables and quality standards. Qualifications: -MS or PhD in Biostatistics, Mathematics, or related discipline. -Experience in Pharma and Oncology required. -Experience in statistical analysis plans, drug development, program design, interpretation and data analysis. -Submissions and regulatory interaction experience. -Proven leader and technical expert. Smith Hanley is a niche recruiting agency. To view our jobs, please go to http://jobs.smithhanley.com/

Smith Hanley Associates Biostatistics Lead Gaithersburg, MD Nihar Parikh, nparikh@smithhanley.com Responsibilities: -Indication lead and global submissions, statistical contributions to design -Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation. -Oversee Partners/CRO on Deliverables and Quality Standards -Apply statistical approaches for value demonstration and regulatory guidance -Global relationship development with collaborative groups, consultants, and international opinion leaders -Statistical staff technical mentoring/coaching and educational support Qualifications: -PhD/MS in Biostatistics, Mathematics, etc. -Experience in Healthcare/Pharma and Oncology, Respiratory, Cardiovascular, Diabetes or similar therapeutic area -Experience in statistical expertise to complex problems; extensive Regulatory and technical knowledge -Experience in Development, Program Design, Interpretation and Data Analysis -Submissions and regulatory interaction experience -Proven leadership experience www.smithhanley.com

Smith Hanley Associates Statistical Programmer - Associate Director/Director Washington DC area Nihar Parikh - nparikh@smithhanley.com In this role you will lead programming projects, support regulatory submissions, clinical development plans, technical data standards and reporting within Oncology, Immuno-oncology, or similar area. Seeking experienced programmers with attention to detail and ability to manage multiple projects. -Provide statistical programming expertise, regulatory submissions, and manage the clinical development process -Manage direct reports and implement CSR development as well as statistical methodologies -SDTM and ADaM datasets, technical expertise and quality of deliverables -Information infrastructure, safety and efficacy of the data, quality improvements -Seeking candidates with a degree in Biostatistics, Applied Mathematics, Engineering, Life Sciences or related fields. -Extensive SAS programming and pharmaceutical experience required -Experience in Oncology, Immuno-oncology, Respiratory or similar therapeutic area -Experience in CDISC standards, regulatory submissions, and clinical drug development -Advanced problem solving and ability to lead/mentor teams Smith Hanley is a niche recruiting agency. To view our jobs, please go to http://jobs.smithhanley.com/ #GD

Smith Hanley Associates Principal Biostatistician Washington DC area Nihar Parikh, nparikh@smithhanley.com Exciting opening for an experienced Biostatistician to be part of a global biopharma with a robust pipeline of products. Responsibilities: -Provide statistical expertise, design clinical studies and lead project teams. -Program design, strategic input, modeling and simulation, as well as statistical innovation. -Deliver global regulatory submissions, interpret clinical programs and develop statistical analysis plans. -Apply statistical principles to provide solutions to problems in drug research. -Statistical staff technical mentoring/coaching. Qualifications: -MS/PhD in Biostatistics, Mathematics, or related field and 5+ years of experience in Healthcare/Pharma. -Background in Oncology, Respiratory or similar therapeutic area and strong statistical methodology. -Experience in regulatory submissions, clinical development and statistical analysis plans. -Experience in program design, statistical protocol and regulatory interactions. -Experience in SAS/R programming. -Strong communication skills. Smith Hanley Associates is a niche recruiting agency: www.smithhanley.com 2018NP

Title-Sr. Mgr., Marketing Advanced Analytics-PHARMA Salary- $130-165k + bonus (depends on experience) Location- Central NJ Consultant -Eda Zullo, ezullo@smithhanley.com #GD My client, a Premier PHARMA company, is seeking a "Sr. Manager, Marketing Advanced Analytics-PHARMA" professional! The main function of this role will be responsible identifying and answering critical questions to the business through performance reporting and advanced analytics. You will collaborate with other business units Responsibilities *Identify business opportunities and potential risks through data and analytics. *Manage an analyst *Set weekly and monthly performance reports and analytics *Able to answer critical business questions through 2ndry data analytics, resource allocation, optimization, targeting & segmentation, and copay analytics Requirements BA degree-/A preferred *5+ years of PHARMA Commercial Analytics-: marketing mix optimization, promotion response modeling, sales force sizing and structure, Segmentation/targeting/call planning), test/control analysis, simulation, and/or decision analysis *Extensive knowledge of various industry data sources such as: IMS Rx data (xPonent, xPonent Plantrak, DDD and HCOS) or Symphony Rx data (Prescriber, Prescriber/Payer, PHAST) , Patient Claims data, Patient Longitudinal data *Must be hands on with SAS, SQL, Access, Excel, PowerPoint, and other analytical reporting tools

  Pharmaceutical  Calibration Specialist Project Description: The client is a large pharmaceutical company seeking a calibration specialist that is capable of calibrating all types of process instrumentation.   Day to Day Responsibilities: This individual must have at least 5 years of calibration experience. Specifically, they will be responsible for the calibration of all types of process instrumentation. The client utilizes a CMMS called Blue Mountain Regulatory System that this person will be working with. It is important the resource have exposure to dealing with some type of computerized maintenance management system. They will also be responsible for reviewing SOP’ s and must be capable of completing a summary review of their findings. Required Skills: Pharmaceutical Calibration – instrumentation (minimum 5 years) Process Instrumentation (temp, pressure, flow, level) CMMS Experience (computerized maintenance management system) Read SOP’ s Desired Skills: Blue Mountain Regulatory CMS System Job Type: Contract   

  Test Method Validation – Chemist (Cleaning Residual Methods) Environment: Our client is a large aseptic manufacturing plant. Looking for someone to help conduct method development, method validation and method transfer for cleaning residual methods.   Duties/Responsibilities/Scope of Work Ideally this person will have experience with cleaning agent HPLC method development and validation . Must have knowledge with swab coupon recovery studies . Need to posses excellent oral and written communication skills for participating in problem-solving teams and customer visits, as necessary.    Other requirements include but not limited to ability to work within tight deadlines as required.  Thorough understanding of commonly used analytical equipment, its function and operation. Such equipment includes HPLC, UV-Vis and IR spectrophotometers, gas chromatograph, liquid chromatograph, incubator, oven, analytical scale, centrifuge, etc.  Maintain a chemically hygienic working environment.  Required Experience: Pharmaceutical Experience HPLC Method Development Swab Coupon Recovery Studies Method Validation Job Type: Contract