Director Statistical Programming
Director, Statistical Programming โ Salary: $250,000/yr- $280,000/yr, Hybrid, Full-time * Director โ โ Revolution Medicines is the worlds leading clinical-stage precision oncology company hyper-focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. โ โ The Director will be responsible for: โ Provide management and oversight of statistical programming resources including FTEs, contractors and CROs (e.g., SDTM vendors, independent statistical analysis center for DMCs) Provide timeline and resource forecasts for statistical programming deliverables. Ensure quality and timely delivery of analysis for our clinical trials. Collaborating with internal team members effectively to help develop/enhance/maintain global macros and processes. Ensure accuracy of clinical trial results for internal and external audiences (e.g., regulatory authorities, academic community, and healthcare providers) via QC of documents with clinical data. Ensure that the interpretation of data obtained from our clinical trials is accurate and the process conforms to the SOPs and Work Practice guidelines. Oversee Programming support for relevant deliverables, such as Investigator Brochures, publications, US, and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation (Define.xml), Reviewer's Guide (SDRG, ADRG), TLFs, Statistical Analysis Plans (study specific, ISS, ISE, Exposure-Response), CRF reviews. Hands-on programming of in-house deliverables including but not limited to Dose Committee meetings, Board of Director meetings, Exploratory Analysis, etc. Verification and review of documents, spreadsheets, slides for in-house presentations and external publications. โ โ The Director should have the following qualifications: โ MS, BS/BA degree or other suitable qualification with relevance to the field. Hands-on experience in programming for early-stage clinical trials. A demonstrable record of strong leadership and teamwork. Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment. Effective, Customer Focused, Responsive, Accountable, and possesses excellent written and verbal communication skills. Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute is extremely important. Industry experience is essential. โ โ Benefits: Stipend for gas Half days Fridays Free Breakfast/Lunch โ If you are interested in Associate Director, Statistical Programmer, please apply today.
US$250000 - US$280000 per year
United States of America
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Senior Clinical Data Manager
We're currently working with an established Biotech company that is looking to add a Senior Clinical Data Manager to expand their growing team and small company team environment. They're currently looking for someone with previous Senior Clinical Data Management experience working with prior early phase/phase II clinical trial experience. Prior history working with Inflammatory Disease and Immuno-Oncology would be a bonus. This Sr Clinical Data Manager position will: Represent Data Management at Study Team Meetings Lead the development of data edit checks specification and data listings Provide input of data-sets, validation plan specification, as well as performing data submission review. Develop or lead the development of the Data Management Plan for a clinical study. Perform reconciliation of data from external data sources against the clinical database Perform quick hypothesis generation and perform UAT testing The Sr Clinical Data Manager should have: 8+ years experience in Clinical Data Management clinical trials in a Biotech/Pharma environment. Experienced working with Various EDC's (Medidata Rave, Oracle, Inform) Experience with Clinical development/trial conduct, including ICH-GCP Inflammatory Disease and Immun-Oncology experience (A Bonus) CRO Oversight/Vendor Management experience Experienced working in Study Start-up through Close-Out Benefits/perks: Remote Opportunity Benefits; (Health, Dental, Vision) W2 Only, No C2C
US$75 - US$95 per hour
San Francisco
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Statistical Programmer
Job Title: Statistical Programmer Company: Clinical Research Organization Location: United States, Remote Job Type: Full-time About Us: I am partnered with a leading provider of clinical research services dedicated to advancing healthcare through innovative and efficient solutions. With a commitment to excellence, they collaborate with pharmaceutical and biotechnology companies to bring new therapies to market. Their team is composed of passionate professionals who play a crucial role in shaping the future of healthcare. Position Overview: We are seeking a talented and experienced Statistical Programmer to join our dynamic team. As a Statistical Programmer, you will contribute to the success of clinical trials by providing expertise in statistical programming and analysis. The successful candidate will play a key role in supporting our clients' research objectives and ensuring the integrity and accuracy of clinical trial data. Responsibilities: Collaborate with statisticians and other team members to develop and validate statistical programs for clinical trials. Generate tables, listings, and graphs for clinical study reports and regulatory submissions. Implement and maintain analysis datasets according to the study protocol and statistical analysis plan. Perform quality control checks on programmed outputs to ensure accuracy and consistency. Contribute to the development and documentation of programming standards and procedures. Stay informed about industry trends and best practices in statistical programming. Qualifications: Bachelor's or advanced degree in statistics, biostatistics, or a related field. Proven experience in statistical programming within a clinical research or pharmaceutical environment. Proficiency in SAS programming; familiarity with other programming languages is a plus. Strong understanding of CDISC standards and regulatory requirements for clinical trials. Excellent problem-solving and communication skills. Ability to work independently and collaboratively in a fast-paced environment. Benefits: Competitive salary commensurate with experience. Comprehensive health and dental insurance. Retirement savings plan with company match. Professional development opportunities. A supportive and collaborative work environment. How to Apply: Interested candidates are invited to submit their resume and a cover letter detailing their relevant experience and qualifications Please include "Statistical Programmer Application" in the subject line.
US$85000 - US$85001 per year
United States of America
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Associate Director, Statistical Programming
Associate Director, Statistical Programming Salary: $175,000/yr- $210,000/yr, + 25% Target Bonus + Substantial Equity Fully Remote (candidates must be based in the PST Time Zone) Our client is a cutting edge Oncology company with a truly robust pipeline aimed at developing novel therapies that treat Cancer. This company has two innovative platforms that collectively have 9 different indications in various phases of development. What is particularly exciting about this company is that not only will you get to contribute to some early phase studies. They also have 3 indications in Phase 3 of development showing a high promise of entering commercialization in 2024. If you are looking for an opportunity to gain exposure to multiple phases of development and join a company right before a massive inflection point don't hesitate to apply. The Associate Director will be responsible for: Provide management and oversight of statistical programming resources including FTEs, contractors and CROs (e.g., SDTM vendors, independent statistical analysis center for DMCs) Provide timeline and resource forecasts for statistical programming deliverables. Ensure quality and timely delivery of analysis for our clinical trials. Collaborating with internal team members effectively to help develop/enhance/maintain global macros and processes. Ensure accuracy of clinical trial results for internal and external audiences (e.g., regulatory authorities, academic community, and healthcare providers) via QC of documents with clinical data. Ensure that the interpretation of data obtained from our clinical trials is accurate and the process conforms to the SOPs and Work Practice guidelines. Oversee Programming support for relevant deliverables, such as Investigator Brochures, publications, US, and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation (Define.xml), Reviewer's Guide (SDRG, ADRG), TLFs, Statistical Analysis Plans (study specific, ISS, ISE, Exposure-Response), CRF reviews. Hands-on programming of in-house deliverables including but not limited to Dose Committee meetings, Board of Director meetings, Exploratory Analysis, etc. Verification and review of documents, spreadsheets, slides for in-house presentations and external publications. The Associate Director should have the following qualifications: MS, BS/BA degree or other suitable qualification with relevance to the field. Hands-on experience in programming for early-stage clinical trials. A demonstrable record of strong leadership and teamwork. Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment. Effective, Customer Focused, Responsive, Accountable, and possesses excellent written and verbal communication skills. Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute is extremely important. Industry experience is essential. Benefits: Stipend for gas Half days Fridays Breakfast/Lunch stipend Medical Benefits fully covered by the company 5 weeks PTO If you are interested in Associate Director, Statistical Programmer, please apply today
Negotiable
San Francisco
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Senior Manager, Statistical Programming
A top Pharmaceutical company seeking a highly skilled Senior Manager, Statistical Programming to join the team! You will provide technical leadership and support on all statistical programming activities. The Senior Manager, Statistical Programming will lead programming in collaboration with partnering functions and develop collaborative relationships. Responsibilities: Lead programming efforts and collaborate with partnering functions Handle and lead programming support within multiple studies or projects in various study activities to ensure timely and high-quality programming deliverables Lead and support global regulatory authority submissions, including preparing programming deliverable for submission Interact cross-functionally with biostatistics, clinical data management, medical writing, clinical operations, drug safety, regulatory and medical, etc. to design, write, and validate SAS programs in accordance with company, industry, and regulatory requirements Qualifications Masters in Statistics, Mathematics, or related field 8+ years of programming experience - preferably within processing clinical trial data in the biotechnology, pharmaceutical, or clinical research organization industry People & project management experience Experience using SAS and R programming languages Experience implementing CDISC standards (ADaM/SDTM) Salary: $150,000 - $180,000 Location: Remote | Must be based in the United States of America *Full-time/ Permanent position*
US$150000 - US$180000 per year
United States of America
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AD Statistics
We have a current opportunity for a Full Time AD Statistics on a permanent basis. The office site location is in New Jersey. For further information about this position please apply. Responsibilities: Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments. Develop statistical sections of clinical development plans, protocols, statistical analysis plans, and key specifications for statistical programming implementation of analyses Strong analytical and problem-solving capabilities Collaborate with and manage internal and external functions Ability to provide guidance to lower level biostatisticians in solving problems. Ability to collaborate Cross Functionally with Biostatistics, Clinical Operations, and Data Management Propensity Score Modeling / Causal Inference experience is a plus! Requirements: MS/PhD in Math/Statistics, Biostatistics, Computer Science (science related) At least 5 years experience in a biotech or pharmaceutical company Experience with Gene Therapy/Rare Disease/Oncology is a plus! Excellent statistical knowledge with the ability of applying the knowledge to solve scientific and clinical problems.
US$170000 - US$210000 per year
New Jersey
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Senior Biostatistician
Position Overview: We are seeking a highly skilled and experienced Senior Biostatistician to join our dynamic team. As a Senior Biostatistician, you will play a crucial role in the design, analysis, and interpretation of clinical trial data, contributing directly to the success of our research programs. Responsibilities: Lead and oversee statistical aspects of clinical research projects, ensuring the highest quality standards and compliance with regulatory requirements. Collaborate with cross-functional teams, including clinical operations, data management, and medical affairs, to develop statistical analysis plans and study protocols. Perform statistical analyses and provide interpretation of results for clinical trial data, contributing to the preparation of study reports and regulatory submissions. Provide statistical expertise in the development of study designs, sample size calculations, and randomization procedures. Review and validate statistical outputs generated by junior statisticians or statistical programmers. Stay abreast of industry trends, regulatory guidelines, and best practices in biostatistics. Qualifications: Master's or Ph.D. in Biostatistics, Statistics, or a related field. Minimum of [X] years of experience in biostatistics within the pharmaceutical, biotechnology, or CRO industry. Proficient in statistical software such as SAS or R. Strong knowledge of regulatory requirements and guidelines related to clinical trials. Excellent communication skills, with the ability to convey complex statistical concepts to non-statisticians. Proven leadership and mentoring skills. Benefits: Competitive salary and performance-based bonuses. Comprehensive health and wellness benefits. Retirement savings plan. Professional development opportunities. Collaborative and innovative work environment.
US$135000 - US$145000 per year
New Jersey
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AD Biostatistics
Key Responsibilities: Statistical Design and Analysis: Spearhead the development of advanced statistical methodologies for oncology clinical trials. Craft and scrutinize statistical analysis plans to ensure precision and reliability. Data Management: Oversee the meticulous collection, integration, and validation of pivotal clinical trial data. Institute rigorous quality control procedures to safeguard data accuracy and integrity. Clinical Trial Support: Contribute strategic statistical insights for protocol development, encompassing sample size calculations. Collaborate closely with clinical teams to decipher study results and contribute to comprehensive clinical study reports. Regulatory Submissions: Lead the preparation and meticulous review of statistical sections in regulatory submissions, ensuring strict compliance. Collaboration and Communication: Engage seamlessly with cross-functional teams, presenting sophisticated statistical findings to internal and external stakeholders. Play a pivotal role in interfacing with regulatory authorities during critical interactions. Qualifications: Education: Master's or Ph.D. in Biostatistics, Statistics, or a related field. Experience: Proven track record in designing and analyzing oncology clinical trials. Mastery of statistical software (e.g., SAS, R) and adeptness in data visualization tools. Skills: Exemplary problem-solving skills with an unwavering attention to detail. Superlative communication skills, capable of elucidating complex statistical concepts.
US$170000 - US$200000 per year
United States of America
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Director Statistical Programming
My client a Growing Biotech, is Looking to Bring on a Dynamic and Experienced Director of Statistical Programming Are you a seasoned statistical programmer with a passion for innovation and a knack for building high-performing teams? Do you thrive in a dynamic environment where you can make a tangible impact on the lives of others? If so, we encourage you to explore this exciting opportunity to lead our statistical programming function at a leading biotechnology company. About the Biotech They are a rapidly growing biotech company committed to developing groundbreaking treatments for debilitating diseases. Their team of passionate scientists and researchers is driven by a shared vision of improving the lives of patients worldwide. They foster a collaborative and supportive environment where individuals are empowered to make meaningful contributions. About the Role As their Director of Statistical Programming, you will play a pivotal role in shaping the future of their clinical programs. You will be responsible for developing and implementing programming strategies, overseeing programming activities, and building a team of exceptional programmers to support their expanding pipeline. Key Responsibilities * Build out a team & lead/mentor a team of statistical programmers to support clinical trials and pipelines * Develop and implement programming processes, standards, and SOPs to ensure data quality and integrity * Effectively manage programming activities on projects and studies, including overseeing CROs * Collaborate with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other functions to deliver high-quality data deliverables * Review and validate SAS programs for standard (SDTM, ADaM) and non-standard (custom study-specific) datasets and TFLs * Develop SAS programming infrastructure and programming processes to enable efficient data deliverables and ad-hoc analyses * Generate ad-hoc analyses on an ongoing basis Qualifications * A minimum of 10 years statistical programming experience coming from Direct Pharma * Advanced SAS programming skills and experience in other statistical software, such as R, etc. * In-depth knowledge of CDISC standards, including SDTM, ADaM, and controlled terminologies * Excellent organizational and communication skills, with the ability to prioritize tasks and work effectively in a fast-paced environment * Proven experience managing CROs and other data vendors * Strong leadership skills, with a growth mindset, willingness to learn from others * Ability to keep pace in a fast-moving organization and adapt to changes * Advanced knowledge of state-of-the-art statistical programming methods in the clinical study setting * Familiarity with ICH guidelines and FDA/EMA/other regulatory authority guidance What We Offer * Competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare, and retirement benefits * Flexible PTO and generous paid time off * Commitment to professional development and growth * 100% remote work arrangement with regular in-person team meetings to foster connections and collaboration Join Their Team and Make a Lasting Impact If you are ready to take your career to the next level and join a company that is truly making a difference in the world, we encourage you to apply for this exciting opportunity.
US$225000 - US$235000 per year + Bonus, Equity, Etc.
United States Virgin Island
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Senior Biostatistician
Seeking a Senior Biostatistician to join the team of a global Contract Research Organization in Cambridge, MA. As a Senior Biostatistician, you will be responsible for leading statistical analysis plans, developing statistical models, and providing statistical expertise to our clients. Working among national and international biopharmaceutical and medical device companies, you will gain experience in various therapeutic areas, developing some of the most innovative and auspicious new therapies available. Responsibilities: Lead statistical projects from inception to completion Provide statistical input into study design, protocol development, and statistical analysis plans Develop statistical analysis plans and perform statistical analyses Provide statistical input to clinical study reports Provide statistical support for publications and presentations Provide statistical support for regulatory submissions Manage timelines and resources for statistical projects Ensure statistical deliverables meet quality standards Ensure compliance with regulatory requirements Provide statistical training and guidance to junior staff Required Skills: Strong statistical background with at least 5+ years of experience Experience in the CRO industry Strong programming skills in SAS Strong communication skills Strong project management skills Strong problem-solving skills Qualifications: PhD or Masters in Statistics, Mathematics, or related field 5 to 7 years of relevant experience (dependent on degree) If you're interested in learning more, please apply!
US$135000 - US$155000 per year
Cambridge
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Associate Director Biostatistics
Position Overview: As the Associate Director of Biostatistics, you will play a pivotal role in our global research and development efforts. You will lead a team of experienced biostatisticians, guiding the statistical strategy and ensuring the highest level of statistical rigor in our clinical trials and research projects. This role is critical to the success of our mission to bring life-changing medicines to patients worldwide. โ Key Responsibilities: Provide strategic leadership in the development and execution of statistical plans for clinical trials and research studies. Collaborate with cross-functional teams to design and implement statistical methodologies in clinical research. Oversee the production of statistical analysis, interpretation of results, and presentation to regulatory authorities. Develop and maintain strong relationships with regulatory agencies, external partners, and key stakeholders. Mentor, manage, and lead a team of biostatisticians, fostering their professional growth and development. Contribute to the development and implementation of best practices, standard operating procedures, and continuous improvement in the biostatistics department. โ Qualifications: Must have Ph.D. in Statistics, Biostatistics, or a related field. Extensive experience in the pharmaceutical or biotechnology industry, with a proven track record in clinical trial design, analysis, and regulatory submissions. Strong leadership and people management skills, with a minimum of 3 years in a managerial or leadership role. In-depth knowledge of statistical methodologies and regulatory requirements (ICH, FDA, EMA, etc.). Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Experience with statistical software such as SAS, R, or similar tools. Strategic thinking and problem-solving abilities. Proven ability to work in a fast-paced and highly regulated environment. โ What We Offer: Competitive salary and bonus structure. Comprehensive benefits package, including health, dental, and retirement plans. Opportunities for professional development and career advancement. A collaborative and innovative work environment. The chance to contribute to groundbreaking research and the development of life-saving drugs.
US$200000 - US$215000 per year
Massachusetts
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